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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, Electrical
510(k) Number K971390
Device Name QUANTUM 3080SP SURGICAL TABLE
Applicant
STERIS Corporation
5960 Heisley Rd.
Mentor,  OH  44060
Applicant Contact LORI HALLER
Correspondent
STERIS Corporation
5960 Heisley Rd.
Mentor,  OH  44060
Correspondent Contact LORI HALLER
Regulation Number878.4960
Classification Product Code
GDC  
Subsequent Product Code
FQO  
Date Received04/14/1997
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
Predetermined Change
Control Plan Authorized		 No
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