The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Sepramesh Ip Bioresorbable Barrier - Permanent Mesh.
Device ID | K040868 |
510k Number | K040868 |
Device Name: | SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH |
Classification | Mesh, Surgical |
Applicant | GENZYME CORP. 500 KENDALL STREET Cambridge, MA 02142 |
Contact | Michael G Halpin |
Correspondent | Michael G Halpin GENZYME CORP. 500 KENDALL STREET Cambridge, MA 02142 |
Product Code | FTM |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-04-02 |
Decision Date | 2004-06-04 |
Summary: | summary |