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Medical Device Reports; Reports of Corrections and Removals; Establishment Registration and Device Listing: Premarket Approval Supplements; Quality System Regulation; Importation of Electronic Products; Technical Amendment; Correction

---
identifier: "/us/fr/04-10265"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Medical Device Reports; Reports of Corrections and Removals; Establishment Registration and Device Listing: Premarket Approval Supplements; Quality System Regulation; Importation of Electronic Products; Technical Amendment; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "04-10265"
section_name: "Medical Device Reports; Reports of Corrections and Removals; Establishment Registration and Device Listing: Premarket Approval Supplements; Quality System Regulation; Importation of Electronic Products; Technical Amendment; Correction"
positive_law: false
currency: "2004-05-07"
last_updated: "2004-05-07"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "04-10265"
document_type: "rule"
publication_date: "2004-05-07"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
cfr_references:
  - "21 CFR Part 807"
fr_citation: "69 FR 25489"
fr_volume: 69
effective_date: "2004-05-07"
fr_action: "Final rule; technical amendment; correction."
---

#  [Corrected]

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Final rule; technical amendment; correction.

**SUMMARY:**

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the *Federal Register* of April 8, 2004 (69 FR 18472). That document corrected a final rule that appeared in the *Federal Register* of March 10, 2004 (69 FR 11310). The April 8, 2004, document published with inadvertent errors. This document corrects those errors.

**DATES:**

This rule is effective May 7, 2004.

**FOR FURTHER INFORMATION CONTACT:**

Joyce A. Strong, Office of Policy and Planning (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010.

**SUPPLEMENTARY INFORMATION:**

In FR Doc. 04-8022, appearing on page 18472 in the *Federal Register* of Thursday, April 8, 2004, the following corrections are made:

1. On page 18472, in the third column, under the *FOR FURTHER INFORMATION CONTACT* heading, the address is corrected to read “Joyce A. Strong, Office of Policy and Planning (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010.”

§ 807.22

2. On page 18473, in the first column, in § 807.22, in paragraph (a), the first sentence is corrected to read “The first registration of a device establishment shall be on Form FDA-2891 (Initial Registration of Device Establishment).”

Dated: April 29, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.