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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number878.4960
Classification Product Code
FQO  
Date Received01/21/2009
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
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