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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 K061973
Device Name SYNTHES 3.5MM SPRING PLATE
Applicant
SYNTHES (USA)
1301 GOSHEN PKWY
WEST CHESTER,  PA  19380
Applicant Contact DEBORAH L JACKSON
Correspondent
SYNTHES (USA)
1301 GOSHEN PKWY
WEST CHESTER,  PA  19380
Correspondent Contact DEBORAH L JACKSON
Regulation Number888.3030
Classification Product Code
HRS  
Date Received07/12/2006
Decision Date 09/11/2006
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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