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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Plate, Cranioplasty
510(k) Number K141385
Device Name DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)
Applicant
Depuy Synthes Companies of Johnson & Johnson
1230 Wilson Dr.
West Chester,  PA  19380
Applicant Contact JEFFREY DOW
Correspondent
Depuy Synthes Companies of Johnson & Johnson
1230 Wilson Dr.
West Chester,  PA  19380
Correspondent Contact JEFFREY DOW
Regulation Number882.5360
Classification Product Code
HBW  
Date Received05/27/2014
Decision Date 03/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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