Device Classification Name |
handle, scalpel
|
510(k) Number |
K852042 |
Device Name |
BRIMFIELD CANNULATED BLADE HOLDER |
Applicant |
BRIMFIELD SCIENTIFIC INSTRUMENTS |
MILL LN. RD. |
BRIMFIELD,
MA
01010
|
|
Applicant Contact |
DAVID W ANTONOPOULO |
Correspondent |
BRIMFIELD SCIENTIFIC INSTRUMENTS |
MILL LN. RD. |
BRIMFIELD,
MA
01010
|
|
Correspondent Contact |
DAVID W ANTONOPOULO |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 05/09/1985 |
Decision Date | 06/11/1985 |
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
|