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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 K964013
Device Name MITEK ABSORBABLE TOGGLE 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 Number888.3030
Classification Product Code
MAI  
Date Received10/07/1996
Decision Date 02/24/1997
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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