The following data is part of a premarket notification filed by Sofradim Production with the FDA for Parietex Progrip.
Device ID | K103682 |
510k Number | K103682 |
Device Name: | PARIETEX PROGRIP |
Classification | Mesh, Surgical, Polymeric |
Applicant | SOFRADIM PRODUCTION 15 CROSBY DRIVE Bedford, MA 01730 |
Contact | James Mcmahon |
Correspondent | James Mcmahon SOFRADIM PRODUCTION 15 CROSBY DRIVE Bedford, MA 01730 |
Product Code | FTL |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-12-17 |
Decision Date | 2011-03-04 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PARIETEX PROGRIP 79039712 3409475 Dead/Cancelled |
SOFRADIM PRODUCTION (Société Par Actions Simplifiée Unipersonnelle) 2007-04-23 |