The following data is part of a premarket notification filed by Doctor's Research Group, Inc. with the FDA for Drg Sherlock Mf Bone Screw, Cocrmo Self-tapping, Ti Alloy Self-tapping/self Drilling, Cocrmo Self-tapping/ Self Drilling.
Device ID | K981881 |
510k Number | K981881 |
Device Name: | DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING |
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 | 1998-05-28 |
Decision Date | 1998-12-02 |