The following data is part of a premarket notification filed by Davol Inc., Sub. C.r. Bard, Inc. with the FDA for Bard Perfix Light Plug, Models 0117050, 0117060, 0117070, 0117080, 0117150, 0117160.
| Device ID | K092032 |
| 510k Number | K092032 |
| Device Name: | BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160 |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | DAVOL INC., SUB. C.R. BARD, INC. 100 CROSSINGS BLVD Warwick, RI 02886 |
| Contact | Gail Dow |
| Correspondent | Gail Dow DAVOL INC., SUB. C.R. BARD, INC. 100 CROSSINGS BLVD Warwick, RI 02886 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-06 |
| Decision Date | 2009-12-08 |
| Summary: | summary |