The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Proceed Ventral Patch.
Device ID | K061533 |
510k Number | K061533 |
Device Name: | PROCEED VENTRAL PATCH |
Classification | Mesh, Surgical, Polymeric |
Applicant | ETHICON, INC. RT. 22 WEST P.O. BOX 151 Somerville, NJ 08876 |
Contact | Bryan A Lisa |
Correspondent | Bryan A Lisa ETHICON, INC. RT. 22 WEST P.O. BOX 151 Somerville, NJ 08876 |
Product Code | FTL |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-06-02 |
Decision Date | 2006-12-11 |
Summary: | summary |