DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING— 510(k) K991608

Name: FDA 510(k) clearance K991608
Creator: U.S. Food and Drug Administration
Published: 1999-07-20

Substantially Equivalent

Dermaphylyx, Inc.

FDA 510(k) clearance K991608 for DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING, Substantially Equivalent on 1999-07-20. Applicant: Dermaphylyx, Inc.. Device class: 1.

Clearance details

Applicant: Dermaphylyx, Inc.
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 1999-05-10
Decision date: 1999-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arvada, CO, US

Download summary PDF View on FDA.gov ↗

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More clearances from Dermaphylyx, Inc.

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K992302 — DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS1999-09-14
K991920 — DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING1999-08-12
K991933 — DERMAPHYLYX FOAM ISLAND DRESSING1999-07-30
K991609 — DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING1999-07-20
K991061 — DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING1999-06-28

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