The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Ventrio Hernia Patch.
Device ID | K100229 |
510k Number | K100229 |
Device Name: | VENTRIO HERNIA PATCH |
Classification | Mesh, Surgical, Polymeric |
Applicant | C.R. BARD, INC. 100 CROSSINGS BOULEVARD Warwick, RI 02886 |
Contact | Michelle Godin |
Correspondent | Michelle Godin C.R. BARD, INC. 100 CROSSINGS BOULEVARD 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 | 2010-01-26 |
Decision Date | 2010-04-21 |
Summary: | summary |