The following data is part of a premarket notification filed by Doctor's Research Group, Inc. with the FDA for Drg Mf Titaniun Alloy Bone Screw 1.0mm, 1.2mm, 1.3mm, 1.5mm, 1.7mm, 2.0mm, 2.4mm.
| Device ID | K974817 |
| 510k Number | K974817 |
| Device Name: | DRG MF TITANIUN ALLOY BONE SCREW 1.0MM, 1.2MM, 1.3MM, 1.5MM, 1.7MM, 2.0MM, 2.4MM |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | DOCTOR'S RESEARCH GROUP, INC. 143 WOLCOTT RD. Wolcott, CT 06716 |
| Contact | Richard Deslauriers |
| Correspondent | Richard Deslauriers DOCTOR'S RESEARCH GROUP, INC. 143 WOLCOTT RD. Wolcott, CT 06716 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-23 |
| Decision Date | 1998-03-13 |