The following data is part of a premarket notification filed by Doctor's Research Group, Inc. with the FDA for Sherlock Threaded Suture Anchor (tin Coated).
Device ID | K982169 |
510k Number | K982169 |
Device Name: | SHERLOCK THREADED SUTURE ANCHOR (TIN COATED) |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
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 | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-06-19 |
Decision Date | 1998-09-14 |