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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Washer, Bolt, Nut, Non-Spinal, Metallic
510(k) Number K052483
Device Name SYNTHES (USA) SPHERICAL WASHERS
Applicant
SYNTHES (USA)
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Applicant Contact LISA M BOYLE
Correspondent
SYNTHES (USA)
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Correspondent Contact LISA M BOYLE
Regulation Number888.3030
Classification Product Code
NDG  
Subsequent Product Code
HWC  
Date Received09/09/2005
Decision Date 11/04/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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