DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING— 510(k) K990875

Name: FDA 510(k) clearance K990875
Creator: U.S. Food and Drug Administration
Published: 1999-05-27

Substantially Equivalent for Some Indications

Dermaphylyx, Inc.

FDA 510(k) clearance K990875 for DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING, Substantially Equivalent for Some Indications on 1999-05-27. Applicant: Dermaphylyx, Inc.. Device class: Unclassified.

Clearance details

Applicant: Dermaphylyx, Inc.
Product code: Code MGP
Device class: Unclassified
Advisory panel: Unknown
Date received: 1999-03-16
Decision date: 1999-05-27
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Arvada, CO, US

Download summary PDF View on FDA.gov ↗

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K991214 — SIMPLICARE TRANSPARENT WOUND DRESSING1999-10-14

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
K991608 — DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING1999-07-20
K991609 — DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING1999-07-20

Adverse events under product code MGP

product code MGP

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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