Device Classification Name |
Scalpel, One-Piece
|
510(k) Number |
K871894 |
Device Name |
KCK INDUSTRIES' SURGICAL INSTRUMENTS |
Applicant |
KCK INDUSTRIES |
4613 ROMBERS PLACE |
WOODLAND HILLS,
CA
91364
|
|
Applicant Contact |
BRUCE R SATHER |
Correspondent |
KCK INDUSTRIES |
4613 ROMBERS PLACE |
WOODLAND HILLS,
CA
91364
|
|
Correspondent Contact |
BRUCE R SATHER |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 05/01/1987 |
Decision Date | 06/23/1987 |
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
|