Device Classification Name |
table, operating-room, ac-powered
|
510(k) Number |
K090136 |
Device Name |
STERIS CMAX XLT SURGICAL TABLE |
Applicant |
STERIS Corporation |
5960 Heisley Road |
Mentor,
OH
44060
|
|
Applicant Contact |
JOHN ROBERT SCOVILLE |
Correspondent |
STERIS Corporation |
5960 Heisley Road |
Mentor,
OH
44060
|
|
Correspondent Contact |
JOHN ROBERT SCOVILLE |
Regulation Number | 878.4960
|
Classification Product Code |
|
Date Received | 01/21/2009 |
Decision Date | 03/20/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|