The following data is part of a premarket notification filed by Sofradim Production with the FDA for Pariefix.
Device ID | K032093 |
510k Number | K032093 |
Device Name: | PARIEFIX |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | SOFRADIM PRODUCTION 5 WHITCOMB AVENUE Ayer, MA 01432 |
Contact | Mary Mcnamara-cullinane |
Correspondent | Mary Mcnamara-cullinane SOFRADIM PRODUCTION 5 WHITCOMB AVENUE Ayer, MA 01432 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-07-07 |
Decision Date | 2003-10-22 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() PARIEFIX 76398360 not registered Dead/Abandoned |
SOFRADIM PRODUCTION 2002-04-22 |