Device Classification Name |
Blade, Saw, General & Plastic Surgery, Surgical
|
510(k) Number |
K861876 |
Device Name |
CRANIO BLADES AND WIRE PASS DRILL |
Applicant |
NEW ENGLAND SURGICAL INSTRUMENT CORP. |
P.O. BOX 35 |
83 EAST WATER STREET |
ROCKLAND,
MA
02370
|
|
Applicant Contact |
KATHLEEN M FEENEY |
Correspondent |
NEW ENGLAND SURGICAL INSTRUMENT CORP. |
P.O. BOX 35 |
83 EAST WATER STREET |
ROCKLAND,
MA
02370
|
|
Correspondent Contact |
KATHLEEN M FEENEY |
Regulation Number | 878.4820
|
Classification Product Code |
|
Date Received | 05/15/1986 |
Decision Date | 05/30/1986 |
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
|