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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 K993261
Device Name TALON ANCHOR SNAP-PAK
Applicant
Mitek Products
60 Glacier Dr.
Westwood,  MA  02090
Applicant Contact PAULA A BULGER
Correspondent
Mitek Products
60 Glacier Dr.
Westwood,  MA  02090
Correspondent Contact PAULA A BULGER
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
GAT  
Date Received09/29/1999
Decision Date 12/02/1999
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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