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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Washer, Bolt Nut
510(k) Number K091763
Device Name MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000
Applicant
Instratek, Inc.
210 Springhill Dr.
Suite 130
Spring,  TX  77386
Applicant Contact Jeff Seavey
Correspondent
Instratek, Inc.
210 Springhill Dr.
Suite 130
Spring,  TX  77386
Correspondent Contact Jeff Seavey
Regulation Number888.3030
Classification Product Code
HTN  
Date Received06/16/2009
Decision Date 08/14/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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