Device Classification Name |
operating room accessories table tray
|
510(k) Number |
K960019 |
Device Name |
RETRACTOR ARM CLAMP |
Applicant |
BIOPSYS MEDICAL, INC. |
3 MORGAN |
IRVINE,
CA
92618
|
|
Applicant Contact |
MARK A COLE |
Correspondent |
BIOPSYS MEDICAL, INC. |
3 MORGAN |
IRVINE,
CA
92618
|
|
Correspondent Contact |
MARK A COLE |
Regulation Number | 878.4950
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/02/1996 |
Decision Date | 02/09/1996 |
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
|