Device Classification Name |
Table, Operating-Room, Ac-Powered
|
510(k) Number |
K971307 |
Device Name |
AMSCO SURGICAL TABLE |
Applicant |
STERIS Corporation |
5960 HEISLEY RD. |
MENTOR,
OH
44060
|
|
Applicant Contact |
MATTHEW M HULL |
Correspondent |
STERIS Corporation |
5960 HEISLEY RD. |
MENTOR,
OH
44060
|
|
Correspondent Contact |
MATTHEW M HULL |
Regulation Number | 878.4960
|
Classification Product Code |
|
Date Received | 04/08/1997 |
Decision Date | 06/27/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|