COMFEEL PLUS WOUND DRESSING— 510(k) K941263

Name: FDA 510(k) clearance K941263
Creator: U.S. Food and Drug Administration
Published: 1994-05-10

Substantially Equivalent

Richard Hamer Assoc., Inc.

FDA 510(k) clearance K941263 for COMFEEL PLUS WOUND DRESSING, Substantially Equivalent on 1994-05-10. 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: 1994-03-16
Decision date: 1994-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KMF

view all

K241916 — TearRepair Liquid Skin Protectant2024-09-27
K182733 — Rochal Bioshield Silicone Film2019-06-27
K171148 — Aleo BME Liquid Bandage2018-01-12
K153571 — Cavilon Advanced High Endurance Skin Protectant2016-08-23
K160684 — Atteris No-Sting Skin Protectant2016-07-26

More clearances from Richard Hamer Assoc., Inc.

view all

K962439 — DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)1996-09-03
K951325 — COMFEEL PLUS PRESSURE RELIEF DRESSING1995-07-31
K950934 — MPM HYDROGEL DRESSING1995-05-16
K951327 — COMFEEL PLUS CONTOUR DRESSING1995-04-28
K942283 — COMFEEL PLUS TRANSPARENT DRESSING1994-07-29

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