Device Classification Name |
table, operating-room, electrical
|
510(k) Number |
K971390 |
Device Name |
QUANTUM 3080SP SURGICAL TABLE |
Applicant |
STERIS Corporation |
5960 Heisley Road |
Mentor,
OH
44060
|
|
Applicant Contact |
LORI HALLER |
Correspondent |
STERIS Corporation |
5960 Heisley Road |
Mentor,
OH
44060
|
|
Correspondent Contact |
LORI HALLER |
Regulation Number | 878.4960
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/14/1997 |
Decision Date | 05/15/1997 |
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
|