The following data is part of a premarket notification filed by Doctor's Research Group, Inc. with the FDA for Drg Titanium Bone Plate.
Device ID | K990920 |
510k Number | K990920 |
Device Name: | DRG TITANIUM BONE PLATE |
Classification | Plate, Bone |
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 | JEY |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-03-18 |
Decision Date | 1999-06-10 |