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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K143716
Device Name DSM Biomedical DPR Cable
Applicant
Dsm Biomedical
735 Pennsylvania Dr.
Exton,  PA  19341
Applicant Contact Lori Burns
Correspondent
Dsm Biomedical
735 Pennsylvania Dr.
Exton,  PA  19341
Correspondent Contact Tom Maguire
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received12/29/2014
Decision Date 10/29/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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