The following data is part of a premarket notification filed by Sofradim Production with the FDA for Modification To Parietex Composite (pco) Mesh.
Device ID | K040998 |
510k Number | K040998 |
Device Name: | MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH |
Classification | Mesh, Surgical, Polymeric |
Applicant | SOFRADIM PRODUCTION 5 WHITCOMB AVENUE Ayer, MA 01432 |
Contact | Mary Mcnamara-cullinane, Rac |
Correspondent | Mary Mcnamara-cullinane, Rac SOFRADIM PRODUCTION 5 WHITCOMB AVENUE Ayer, MA 01432 |
Product Code | FTL |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-04-19 |
Decision Date | 2004-04-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10884521178465 | K040998 | 000 |
10884521178458 | K040998 | 000 |
10884521178472 | K040998 | 000 |