MODIFICATION TO: OCU-FILM TIP COVER— 510(k) K070534

Name: FDA 510(k) clearance K070534
Creator: U.S. Food and Drug Administration
Published: 2007-03-27

Substantially Equivalent

Reichert, Inc.

FDA 510(k) clearance K070534 for MODIFICATION TO: OCU-FILM TIP COVER, Substantially Equivalent on 2007-03-27. Applicant: Reichert, Inc.. Device class: 2.

Clearance details

Applicant: Reichert, Inc.
Product code: Code HKY
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 2007-02-26
Decision date: 2007-03-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Depew, NY, US

Download summary PDF View on FDA.gov ↗

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