The following data is part of a premarket notification filed by Davol, Inc., Sub. C.r. Bard, Inc. with the FDA for Bard Sperma-tex Preshaped Mesh (2.4x5.6), Model 0114700.
| Device ID | K991637 |
| 510k Number | K991637 |
| Device Name: | BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700 |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | DAVOL, INC., SUB. C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD Cranston, RI 02920 |
| Contact | Rini Georgekutty |
| Correspondent | Rini Georgekutty 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 | 1999-05-12 |
| Decision Date | 1999-06-22 |
| Summary: | summary |