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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Bed, Ac-Powered Adjustable Hospital
510(k) Number K964515
Device Name ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002
Applicant
M.C. HEALTHCARE PRODUCTS, INC.
4658 ONTARIO ST.
BEAMSVILLE, ONTARIO,  CA L0R 1B4
Applicant Contact RALPH N THOMPSON
Correspondent
M.C. HEALTHCARE PRODUCTS, INC.
4658 ONTARIO ST.
BEAMSVILLE, ONTARIO,  CA L0R 1B4
Correspondent Contact RALPH N THOMPSON
Regulation Number880.5100
Classification Product Code
FNL  
Date Received10/16/1996
Decision Date 12/31/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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