REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES— 510(k) K926586

Substantially Equivalent

Look, Inc.

FDA 510(k) clearance K926586 for REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES, Substantially Equivalent on 1993-12-22. Applicant: Look, Inc..

Clearance details

Applicant
Look, Inc.
Product code
Code GAL
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ada, OK, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code GAL

product code GAL
Malfunction
681
Other
1
Total
682

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.