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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dura Substitute
510(k) Number K113071
Device Name SYNTHECEL DURA REPLACEMENT DEVICES
Applicant
Synthes
1301 Goshen Pkwy.
West Chester,  PA  19380
Applicant Contact ANDREA M TASKER
Correspondent
Synthes
1301 Goshen Pkwy.
West Chester,  PA  19380
Correspondent Contact ANDREA M TASKER
Regulation Number882.5910
Classification Product Code
GXQ  
Date Received10/17/2011
Decision Date 01/09/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT00859508
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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