COMFEEL PLUS TRANSPARENT DRESSING— 510(k) K942283

Name: FDA 510(k) clearance K942283
Creator: U.S. Food and Drug Administration
Published: 1994-07-29

Substantially Equivalent for Some Indications

Richard Hamer Assoc., Inc.

FDA 510(k) clearance K942283 for COMFEEL PLUS TRANSPARENT DRESSING, Substantially Equivalent for Some Indications on 1994-07-29. Applicant: Richard Hamer Assoc., Inc.. Device class: 1.

Clearance details

Applicant: Richard Hamer Assoc., Inc.
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 1994-05-11
Decision date: 1994-07-29
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Fort Worth, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.