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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K071184
Device Name SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM
Applicant
Synthes (Usa)
1301-1303 Goshen Pkwy.
West Chester,  PA  19380
Applicant Contact SHERI L MUSGNUNG
Correspondent
Synthes (Usa)
1301-1303 Goshen Pkwy.
West Chester,  PA  19380
Correspondent Contact SHERI L MUSGNUNG
Regulation Number888.3030
Classification Product Code
HRS  
Date Received04/30/2007
Decision Date 06/22/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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