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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apron, Leaded
510(k) Number K870103
Device Name LEAD APRON CADDY
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 Number892.6500
Classification Product Code
EAJ  
Date Received01/09/1987
Decision Date 01/21/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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