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 |