The following data is part of a premarket notification filed by Genzyme Corporation with the FDA for Sepramesh Ip Bioresorbable Coating/permanent Mesh.
Device ID | K053066 |
510k Number | K053066 |
Device Name: | SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH |
Classification | Mesh, Surgical, Polymeric |
Applicant | GENZYME CORPORATION 55 CAMBRIDGE PARKWAY Cambridge, MA 02142 |
Contact | Lisa D Crockett |
Correspondent | Lisa D Crockett GENZYME CORPORATION 55 CAMBRIDGE PARKWAY Cambridge, MA 02142 |
Product Code | FTL |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-11-01 |
Decision Date | 2005-12-19 |
Summary: | summary |