Device Classification Name |
Light, Surgical, Accessories
|
510(k) Number |
K954940 |
Device Name |
MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE |
Applicant |
MDT BIOLOGIC CO. |
1777 EAST HENRIETTA RD. |
P.O. BOX 23077 |
ROCHESTER,
NY
14692
|
|
Applicant Contact |
CHARLES O HANCOCK |
Correspondent |
MDT BIOLOGIC CO. |
1777 EAST HENRIETTA RD. |
P.O. BOX 23077 |
ROCHESTER,
NY
14692
|
|
Correspondent Contact |
CHARLES O HANCOCK |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 10/30/1995 |
Decision Date | 01/17/1996 |
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
|