COMFORT CUSHION DRY BURN PADS, STERILE— 510(k) K802317

Name: FDA 510(k) clearance K802317
Creator: U.S. Food and Drug Administration
Published: 1980-10-31

Substantially Equivalent

American Convertors Div., American Pharmaseal

FDA 510(k) clearance K802317 for COMFORT CUSHION DRY BURN PADS, STERILE, Substantially Equivalent on 1980-10-31. Applicant: American Convertors Div., American Pharmaseal. Device class: 2.

Clearance details

Applicant: American Convertors Div., American Pharmaseal
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1980-09-23
Decision date: 1980-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K840957 — ANTIMICROBIAL INCISE DRAPE1984-06-07
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K830786 — DISIMETRIC RELEASE OF INSTRANETICS RAD1983-05-18
K820994 — ABSORB FURN SHEET1982-05-13
K813419 — COMFORT CUSHION DRY BURN PAD III1982-01-22

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