Device Classification Name |
scalpel, one-piece
|
510(k) Number |
K820730 |
Device Name |
MICRO CISE DIAMOND SCALPEL |
Applicant |
COOPERVISION, INC. |
PERMALENS HOUSE |
1 BOTLEY ROAD, HEDGE END |
SOUTHAMPTON,
GB
S033HB
|
|
Correspondent |
COOPERVISION, INC. |
PERMALENS HOUSE |
1 BOTLEY ROAD, HEDGE END |
SOUTHAMPTON,
GB
S033HB
|
|
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 03/17/1982 |
Decision Date | 04/09/1982 |
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
|
|
|