The following data is part of a premarket notification filed by American Cyanamid Co. with the FDA for Dexon Ii Absorbable Surgical Suture, U.s.p..
| Device ID | K900198 |
| 510k Number | K900198 |
| Device Name: | DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P. |
| Classification | Suture, Absorbable, Synthetic |
| Applicant | AMERICAN CYANAMID CO. ONE CASPER ST. Danbury, CT 06810 |
| Contact | Robert I Pelletier |
| Correspondent | Robert I Pelletier AMERICAN CYANAMID CO. ONE CASPER ST. Danbury, CT 06810 |
| Product Code | GAN |
| CFR Regulation Number | 878.4830 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-16 |
| Decision Date | 1990-07-05 |