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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K010479
Device Name MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR
Applicant
Bonutti Research, Inc.
2600 S. Raney
P.O. Box 1367
Effingham,  IL  62401
Applicant Contact PATRICK BALSMANN
Correspondent
Bonutti Research, Inc.
2600 S. Raney
P.O. Box 1367
Effingham,  IL  62401
Correspondent Contact PATRICK BALSMANN
Regulation Number888.3040
Classification Product Code
HTY  
Subsequent Product Code
MBI  
Date Received02/20/2001
Decision Date 05/08/2001
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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