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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Manual
510(k) Number K864878
Device Name ICU/CPU TRANSPORT TRAY
Applicant
Orthopedic Systems, Inc.
1897 National Ave.
Hayward,  CA  94545
Applicant Contact ROBERT R MOORE
Correspondent
Orthopedic Systems, Inc.
1897 National Ave.
Hayward,  CA  94545
Correspondent Contact ROBERT R MOORE
Regulation Number880.5120
Classification Product Code
FNJ  
Date Received12/12/1986
Decision Date 01/06/1987
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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