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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue
510(k) Number K052799
Device Name MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM
Applicant
Bonutti Research, Inc.
P.O. Box 1367
Effingham,  IL  62401
Applicant Contact PATRICK BALSMANN
Correspondent
Bonutti Research, Inc.
P.O. Box 1367
Effingham,  IL  62401
Correspondent Contact PATRICK BALSMANN
Regulation Number888.3030
Classification Product Code
MAI  
Date Received10/03/2005
Decision Date 12/16/2005
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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