The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh.
Device ID | K962530 |
510k Number | K962530 |
Device Name: | PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH |
Classification | Mesh, Surgical, Polymeric |
Applicant | ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
Contact | John D Paulson, Ph.d. |
Correspondent | John D Paulson, Ph.d. ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
Product Code | FTL |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-28 |
Decision Date | 1996-08-09 |
Summary: | summary |