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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K133035
Device Name NORMED PELLEGRIN CALCANEUS STOP SCREW
Applicant
Normed Medizin-Technik GmbH
8708 Capehart Cove
Austin,  TX  78733
Applicant Contact DALENE BINKLEY
Correspondent
Normed Medizin-Technik GmbH
8708 Capehart Cove
Austin,  TX  78733
Correspondent Contact DALENE BINKLEY
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/27/2013
Decision Date 12/13/2013
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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