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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 K131264
Device Name KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS
Applicant
Gebr. Brasseler GmbH & Co. KG
1331 H St. NW
12th Floor
Washington,  DC  20005
Applicant Contact ERELA DANA
Correspondent
Gebr. Brasseler GmbH & Co. KG
1331 H St. NW
12th Floor
Washington,  DC  20005
Correspondent Contact ERELA DANA
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Codes
HTY   JDW  
Date Received05/03/2013
Decision Date 07/26/2013
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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