PARIEFIX
Laparoscope, General & Plastic Surgery
SOFRADIM PRODUCTION
The following data is part of a premarket notification filed by Sofradim Production with the FDA for Pariefix.
Pre-market Notification Details
| 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 |
Trademark Results [PARIEFIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PARIEFIX 76398360 not registered Dead/Abandoned |
SOFRADIM PRODUCTION 2002-04-22 |
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