The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Small Perfix Light Plug With 6 X 13.5 Cm Hydrolight Onlay, Medium Perfix Light Plug With 6 X 13.5 Cm Hydrolight Onlay, Large Perfix Light Plug With 6 X 13.5 Cm Hydrolight Onlay, Extra Large Perfix Light Plug With 6 X 13.5 Cm Hydrolight Onlay.
| Device ID | K153236 |
| 510k Number | K153236 |
| Device Name: | Small PerFix Light Plug With 6 X 13.5 Cm HydroLight Onlay, Medium PerFix Light Plug With 6 X 13.5 Cm HydroLight Onlay, Large PerFix Light Plug With 6 X 13.5 Cm HydroLight Onlay, Extra Large PerFix Light Plug With 6 X 13.5 Cm HydroLight Onlay |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | C.R. BARD, INC. 100 CROSSINGS BOULEVARD Warwick, RI 02886 |
| Contact | Shweta Conner |
| Correspondent | Shweta Conner C.R. BARD, INC. 100 CROSSINGS BOULEVARD 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 | 2015-11-09 |
| Decision Date | 2016-05-13 |
| Summary: | summary |