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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K050462
Device Name SBI HAND FIXATION SYSTEM (TM)
Applicant
Small Bone Innovations, LLC
505 Park Ave., 14th Floor
New York,  NY  10022
Applicant Contact DONALD GUTHNER
Correspondent
Small Bone Innovations, LLC
505 Park Ave., 14th Floor
New York,  NY  10022
Correspondent Contact DONALD GUTHNER
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received02/23/2005
Decision Date 04/26/2005
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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