Device Classification Name |
Retention Device, Suture
|
510(k) Number |
K030031 |
Device Name |
SOFT TISSUE ANCHORING WASHERS |
Applicant |
ACCU-SPEED, INCORPORATED |
P.O. BOX 1008, 65 GAY RD. |
GROTON,
MA
01450
|
|
Applicant Contact |
ROBERT W SECOVICH |
Correspondent |
ACCU-SPEED, INCORPORATED |
P.O. BOX 1008, 65 GAY RD. |
GROTON,
MA
01450
|
|
Correspondent Contact |
ROBERT W SECOVICH |
Regulation Number | 878.4930
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/03/2003 |
Decision Date | 01/28/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|