FORMULATION CHANGE IN UNITED SKIN BARR— 510(k) K810726

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K810726 for FORMULATION CHANGE IN UNITED SKIN BARR, Substantially Equivalent on 1981-06-02. Applicant: Howmedica Corp..

Clearance details

Applicant
Howmedica Corp.
Product code
Code EXB
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code EXB

product code EXB
Injury
145
Total
145

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.