HYDROSKIN WOUND DRESSING— 510(k) K942815

Name: FDA 510(k) clearance K942815
Creator: U.S. Food and Drug Administration
Published: 1994-07-11

Substantially Equivalent for Some Indications

Hymedix Intl., Inc.

FDA 510(k) clearance K942815 for HYDROSKIN WOUND DRESSING, Substantially Equivalent for Some Indications on 1994-07-11. Applicant: Hymedix Intl., Inc.. Device class: 1.

Clearance details

Applicant: Hymedix Intl., Inc.
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 1994-06-15
Decision date: 1994-07-11
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Dayton, NJ, US

Download summary PDF View on FDA.gov ↗

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