COMFEEL:ALGINATE DRESSING— 510(k) K953497

Substantially Equivalent

Coloplast A/S

FDA 510(k) clearance K953497 for COMFEEL:ALGINATE DRESSING, Substantially Equivalent on 1995-09-29. Applicant: Coloplast A/S. Device class: 1.

Clearance details

Applicant: Coloplast A/S
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 1995-07-26
Decision date: 1995-09-29
Decision: Substantially Equivalent
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.