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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name operating room accessories table tray
510(k) Number K864881
Device Name ARTHROSCOPIC ANKLE HOLDER
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 Number878.4950
Classification Product Code
FWZ  
Date Received12/12/1986
Decision Date 12/29/1986
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
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