ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013— 510(k) K974891

Substantially Equivalent

Acutek Adhesive Specialties, Inc.

FDA 510(k) clearance K974891 for ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013, Substantially Equivalent on 1998-10-21. Applicant: Acutek Adhesive Specialties, Inc..

Clearance details

Applicant
Acutek Adhesive Specialties, Inc.
Product code
Code MGP
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Inglewood, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code MGP

product code MGP
Other
1
Total
1

Source: openFDA MAUDE database, through . 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.