The following data is part of a premarket notification filed by Davol, Inc., Sub. C.r. Bard, Inc. with the FDA for Bard Composite Prosthesis.
| Device ID | K971745 |
| 510k Number | K971745 |
| Device Name: | BARD COMPOSITE PROSTHESIS |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | DAVOL, INC., SUB. C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD Cranston, RI 02920 |
| Contact | Jeannette G Cloutier |
| Correspondent | Jeannette G Cloutier DAVOL, INC., SUB. C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD Cranston, RI 02920 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-12 |
| Decision Date | 1997-08-06 |
| Summary: | summary |