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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name rod, fixation, intramedullary and accessories
510(k) Number K082148
Device Name SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION
Applicant
SYNTHES (USA)
1301 GOSHEN PKWY.
west chester,  PA  19380
Applicant Contact jill r sherman
Correspondent
SYNTHES (USA)
1301 GOSHEN PKWY.
west chester,  PA  19380
Correspondent Contact jill r sherman
Regulation Number888.3020
Classification Product Code
HSB  
Date Received07/30/2008
Decision Date 08/11/2008
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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