SILON(TM) TRANSPARENT WOUND DRESSING— 510(k) K912032

Name: FDA 510(k) clearance K912032
Creator: U.S. Food and Drug Administration
Published: 1991-08-20

Substantially Equivalent

Bio Med Sciences, Inc.

FDA 510(k) clearance K912032 for SILON(TM) TRANSPARENT WOUND DRESSING, Substantially Equivalent on 1991-08-20. Applicant: Bio Med Sciences, Inc.. Device class: Unclassified.

Clearance details

Applicant: Bio Med Sciences, Inc.
Product code: Code MGP
Device class: Unclassified
Advisory panel: Unknown
Date received: 1991-05-08
Decision date: 1991-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

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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 Bio Med Sciences, Inc.

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K023136 — OLEEVA FABRIC2002-10-16
K002109 — OLEEVA FOAM2000-08-31
K990042 — SILON DUAL-DRESS1999-03-19
K982036 — SILON SCAR STRIPS1998-08-06
K952546 — SILON SILICONE TEXTILE COMPOSITE1995-08-07

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.