DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING— 510(k) K990438

Name: FDA 510(k) clearance K990438
Creator: U.S. Food and Drug Administration
Published: 1999-03-25

Substantially Equivalent

Dermaphylyx, Inc.

FDA 510(k) clearance K990438 for DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING, Substantially Equivalent on 1999-03-25. Applicant: Dermaphylyx, Inc.. Device class: Unclassified.

Clearance details

Applicant: Dermaphylyx, Inc.
Product code: Code MGP
Device class: Unclassified
Advisory panel: Unknown
Date received: 1999-02-11
Decision date: 1999-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arvada, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MGP

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K012995 — COLLATEK SHEET2001-10-25
K012997 — COLLATEK FOAM2001-10-25
K001508 — LASERSKIN DRESSING2001-07-25
K990079 — FASTSEAL CHEST WOUND DRESSING1999-12-23
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.