| Device Classification Name |
Fastener, Fixation, Nondegradable, Soft Tissue
|
| 510(k) Number |
K982169 |
| Device Name |
SHERLOCK THREADED SUTURE ANCHOR (TIN COATED) |
| Applicant |
| Doctor'S Research Group, Inc. |
| 143 Wolcott Rd. |
|
Wolcott,
CT
06716
|
|
| Applicant Contact |
RICHARD DESLAURIERS |
| Correspondent |
| Doctor'S Research Group, Inc. |
| 143 Wolcott Rd. |
|
Wolcott,
CT
06716
|
|
| Correspondent Contact |
RICHARD DESLAURIERS |
| Regulation Number | 888.3040 |
| Classification Product Code |
|
| Date Received | 06/19/1998 |
| Decision Date | 09/14/1998 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Orthopedic
|
| 510k Review Panel |
Orthopedic
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|