BIODERM MEDICAL COMPOSITE WOUND DRESSING— 510(k) K946292

Name: FDA 510(k) clearance K946292
Creator: U.S. Food and Drug Administration
Published: 1995-02-06

Substantially Equivalent

Bioderm, Inc.

FDA 510(k) clearance K946292 for BIODERM MEDICAL COMPOSITE WOUND DRESSING, Substantially Equivalent on 1995-02-06. Applicant: Bioderm, Inc.. Device class: Unclassified.

Clearance details

Applicant: Bioderm, Inc.
Product code: Code MGP
Device class: Unclassified
Advisory panel: Unknown
Date received: 1994-12-27
Decision date: 1995-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheaton, IL, 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 Bioderm, Inc.

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K990955 — MODIFICATION OF:BIODERM FOAM WOUND DRESSING1999-05-18
K982778 — BIODERM FOAM WOUND DRESSING1998-10-21
K982939 — BTF THIN FILM WOUND DRESSING1998-10-13
K980451 — BIODERM CALCIUM ALGINATE DRESSING1998-04-09
K973429 — BIODERM FOAM WOUND DRESSING1997-12-01

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.