The following data is part of a premarket notification filed by American Cyanamid Co. with the FDA for Flexon And Stainless Steel Sutures.
| Device ID | K930992 |
| 510k Number | K930992 |
| Device Name: | FLEXON AND STAINLESS STEEL SUTURES |
| Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Applicant | AMERICAN CYANAMID CO. ONE CASPER ST. Danbury, CT 06810 |
| Contact | John F Schaefer |
| Correspondent | John F Schaefer AMERICAN CYANAMID CO. ONE CASPER ST. Danbury, CT 06810 |
| Product Code | GAQ |
| CFR Regulation Number | 878.4495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-25 |
| Decision Date | 1993-12-17 |