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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K100736
Device Name KIRSCHNER AND GUIDE WIRES
Applicant
Smt Schilling Metalltechnik GmbH
Griesweg 47
Mühlheim An Der Donau,  DE 78570
Applicant Contact ANDRE WEINGERL
Correspondent
Smt Schilling Metalltechnik GmbH
Griesweg 47
Mühlheim An Der Donau,  DE 78570
Correspondent Contact ANDRE WEINGERL
Regulation Number888.3040
Classification Product Code
HTY  
Subsequent Product Code
JDW  
Date Received03/15/2010
Decision Date 09/10/2010
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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