REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES— 510(k) K926586
Substantially EquivalentLook, 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
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.