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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 K983818
Device Name MITEK FASTIN RC ANCHOR
Applicant
Mitek Products
60 Glacier Dr.
Westwood,  MA  02090
Applicant Contact EDWARD F KENT
Correspondent
Mitek Products
60 Glacier Dr.
Westwood,  MA  02090
Correspondent Contact EDWARD F KENT
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Codes
GAM   GAS   HWC  
Date Received10/29/1998
Decision Date 11/23/1998
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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