MITRAFLEX CAVITY WOUND DRESSING— 510(k) K935783

Name: FDA 510(k) clearance K935783
Creator: U.S. Food and Drug Administration
Published: 1994-02-04

Substantially Equivalent for Some Indications

Polymedica Industries, Inc.

FDA 510(k) clearance K935783 for MITRAFLEX CAVITY WOUND DRESSING, Substantially Equivalent for Some Indications on 1994-02-04. Applicant: Polymedica Industries, Inc.. Device class: 1.

Clearance details

Applicant: Polymedica Industries, Inc.
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 1993-12-06
Decision date: 1994-02-04
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Golden,, CO, US

Download summary PDF View on FDA.gov ↗

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