OSMO/PCA PILLOW WOUND DRESSING— 510(k) K971612

Name: FDA 510(k) clearance K971612
Creator: U.S. Food and Drug Administration
Published: 1998-03-16

Substantially Equivalent for Some Indications

Procyte Corp.

FDA 510(k) clearance K971612 for OSMO/PCA PILLOW WOUND DRESSING, Substantially Equivalent for Some Indications on 1998-03-16. Applicant: Procyte Corp.. Device class: 1.

Clearance details

Applicant: Procyte Corp.
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 1997-05-02
Decision date: 1998-03-16
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Kirkland, WA, 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.