The following data is part of a premarket notification filed by Pega Medical Inc. with the FDA for Fassier-duval Telscopic Im System.
| Device ID | K041393 |
| 510k Number | K041393 |
| Device Name: | FASSIER-DUVAL TELSCOPIC IM SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | PEGA MEDICAL INC. 9260 BOUL. VIAU Montreal (quebec), CA H1r 2v8 |
| Contact | Ariel R Dujovne |
| Correspondent | Ariel R Dujovne PEGA MEDICAL INC. 9260 BOUL. VIAU Montreal (quebec), CA H1r 2v8 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-24 |
| Decision Date | 2004-08-17 |
| Summary: | summary |