COMFEEL PLUS CONTOUR DRESSING— 510(k) K951327

Name: FDA 510(k) clearance K951327
Creator: U.S. Food and Drug Administration
Published: 1995-04-28

Substantially Equivalent

Richard Hamer Assoc., Inc.

FDA 510(k) clearance K951327 for COMFEEL PLUS CONTOUR DRESSING, Substantially Equivalent on 1995-04-28. 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: 1995-03-23
Decision date: 1995-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

Download summary PDF View on FDA.gov ↗

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K950934 — MPM HYDROGEL DRESSING1995-05-16
K942283 — COMFEEL PLUS TRANSPARENT DRESSING1994-07-29
K942573 — COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH1994-07-18

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