Device Classification Name |
instrument, surgical, disposable
|
510(k) Number |
K903649 |
Device Name |
BRADLEY TENACULUM HOLDER |
Applicant |
MARLO SURGICAL TECHNOLOGY |
1810 JOSEPH LLOYD PKWY. |
WILLOUGHBY,
OH
44094
|
|
Applicant Contact |
SCOTT C MARLOW |
Correspondent |
MARLO SURGICAL TECHNOLOGY |
1810 JOSEPH LLOYD PKWY. |
WILLOUGHBY,
OH
44094
|
|
Correspondent Contact |
SCOTT C MARLOW |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 08/13/1990 |
Decision Date | 11/02/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|