PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP— 510(k) K000542
Substantially EquivalentArc Medical Supplies (Beijing) Co, Ltd.
FDA 510(k) clearance K000542 for PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP, Substantially Equivalent on 2000-04-28. Applicant: Arc Medical Supplies (Beijing) Co, Ltd..
Clearance details
- Applicant
- Arc Medical Supplies (Beijing) Co, Ltd.
- Product code
- Code GAL
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Syosset, NY, 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.