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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 K081623
Device Name SYNTHES RIB FIXATION SYSTEM
Applicant
SYNTHES (USA)
1301 GOSHEN PKWY
WEST CHESTER,  PA  19380
Applicant Contact AMNON TALMOR
Correspondent
SYNTHES (USA)
1301 GOSHEN PKWY
WEST CHESTER,  PA  19380
Correspondent Contact AMNON TALMOR
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received06/10/2008
Decision Date 09/08/2008
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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