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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K101759
Device Name QUANTUM RING FIXATION SYSTEM MODEL ISF
Applicant
Quantum Medical Concepts, LLC
3518 SE 21st Ave.
Portland,  OR  97202
Applicant Contact ALEXANDER SHAEVITZ
Correspondent
Quantum Medical Concepts, LLC
3518 SE 21st Ave.
Portland,  OR  97202
Correspondent Contact ALEXANDER SHAEVITZ
Regulation Number888.3030
Classification Product Code
KTT  
Date Received06/23/2010
Decision Date 10/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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