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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, Nondegradable, Soft Tissue
510(k) Number K964532
Device Name MULTITAK SS SUTURE SYSTEM
Applicant
Bonutti Research
P.O. Box 1387
1303 Evergreen Ave.
Effingham,  IL  62401
Applicant Contact LYNNETTE WHITAKER
Correspondent
Bonutti Research
P.O. Box 1387
1303 Evergreen Ave.
Effingham,  IL  62401
Correspondent Contact LYNNETTE WHITAKER
Regulation Number888.3040
Classification Product Code
MBI  
Date Received11/12/1996
Decision Date 02/03/1997
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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