The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 1.5mm Ti Brow Lift Screw.
Device ID | K002935 |
510k Number | K002935 |
Device Name: | SYNTHES 1.5MM TI BROW LIFT SCREW |
Classification | Screw, Fixation, Intraosseous |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Contact | Thomas M Maguire |
Correspondent | Thomas M Maguire SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Product Code | DZL |
CFR Regulation Number | 872.4880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-09-21 |
Decision Date | 2000-11-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H9804007010 | K002935 | 000 |