The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Ventralex Hernia Patch.
Device ID | K132441 |
510k Number | K132441 |
Device Name: | BARD VENTRALEX HERNIA PATCH |
Classification | Mesh, Surgical, Polymeric |
Applicant | C.R. BARD, INC. 100 CROSSINGS BLVD. Warwick, RI 02886 |
Contact | Mariya Buharin |
Correspondent | Mariya Buharin C.R. BARD, INC. 100 CROSSINGS BLVD. Warwick, RI 02886 |
Product Code | FTL |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-08-06 |
Decision Date | 2013-12-13 |
Summary: | summary |