TRANSPARENT DRESSING— 510(k) K943111

Name: FDA 510(k) clearance K943111
Creator: U.S. Food and Drug Administration
Published: 1994-09-12

Substantially Equivalent for Some Indications

Acutek Adhesive Specialties, Inc.

FDA 510(k) clearance K943111 for TRANSPARENT DRESSING, Substantially Equivalent for Some Indications on 1994-09-12. Applicant: Acutek Adhesive Specialties, Inc.. Device class: Unclassified.

Clearance details

Applicant: Acutek Adhesive Specialties, Inc.
Product code: Code MGP
Device class: Unclassified
Advisory panel: Unknown
Date received: 1994-06-27
Decision date: 1994-09-12
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Inglewood, CA, US

Download summary PDF View on FDA.gov ↗

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K990079 — FASTSEAL CHEST WOUND DRESSING1999-12-23
K991214 — SIMPLICARE TRANSPARENT WOUND DRESSING1999-10-14

More clearances from Acutek Adhesive Specialties, Inc.

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K974891 — ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 1970131998-10-21
K974890 — ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 9970021998-10-13
K974892 — ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 1970121998-10-13
K962698 — ACUTEK'S CLEARPASAGE1996-09-09
K951644 — ACUTEK'S CLEARPASSAGE1995-07-03

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.