The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Small Bard Ventralex Patch.
Device ID | K024008 |
510k Number | K024008 |
Device Name: | SMALL BARD VENTRALEX PATCH |
Classification | Mesh, Surgical, Polymeric |
Applicant | C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
Contact | Brian A Kanerviko |
Correspondent | Brian A Kanerviko C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 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 | 2002-12-04 |
Decision Date | 2003-02-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10801741000352 | K024008 | 000 |