The following data is part of a premarket notification filed by American Cyanamid Co. with the FDA for Coated Novafil, Polybutester, Mesh.
| Device ID | K896946 |
| 510k Number | K896946 |
| Device Name: | COATED NOVAFIL, POLYBUTESTER, MESH |
| Classification | Mesh, Surgical |
| Applicant | AMERICAN CYANAMID CO. ONE CASPER ST. Danbury, CT 06810 |
| Contact | B. I Parzuchowski |
| Correspondent | B. I Parzuchowski AMERICAN CYANAMID CO. ONE CASPER ST. Danbury, CT 06810 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-13 |
| Decision Date | 1990-05-07 |