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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nail, fixation, bone
510(k) Number K951302
Device Name SMALL FRAGMENT PLATES AND SCREWS
Applicant
MEDPAC
25768 PARADA DR.
VALENCIA,  CA  91355
Applicant Contact ROB MEDOFF
Correspondent
MEDPAC
25768 PARADA DR.
VALENCIA,  CA  91355
Correspondent Contact ROB MEDOFF
Regulation Number888.3030
Classification Product Code
JDS  
Subsequent Product Code
HRS  
Date Received03/22/1995
Decision Date 05/05/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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