K900198 is an FDA 510(k) clearance for the DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.. This device is classified as a Suture, Absorbable, Synthetic (Class II - Special Controls, product code GAN).
Submitted by American Cyanamid Co. (Danbury, US). The FDA issued a Cleared decision on July 5, 1990, 170 days after receiving the submission on January 16, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4830.
| 510(k) Number | K900198 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | January 16, 1990 |
| Decision Date | July 05, 1990 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GAN — Suture, Absorbable, Synthetic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4830 |