DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.— 510(k) K900198
Substantially Equivalent for Some IndicationsAmerican Cyanamid Co.
FDA 510(k) clearance K900198 for DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P., Substantially Equivalent for Some Indications on 1990-07-05. Applicant: American Cyanamid Co..
Clearance details
- Applicant
- American Cyanamid Co.
- Product code
- Code GAN
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Danbury, CT, US
Adverse events under product code GAN
product code GAN- Injury
- 599
- Malfunction
- 1,658
- Total
- 2,257
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.