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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Intraosseous
510(k) Number K992623
Device Name MITEK MINI ANCHOR
Applicant
Mitek Products
60 Glacier Dr.
Westwood,  MA  02090
Applicant Contact PAULA E BULGER
Correspondent
Mitek Products
60 Glacier Dr.
Westwood,  MA  02090
Correspondent Contact PAULA E BULGER
Regulation Number872.4880
Classification Product Code
DZL  
Date Received08/05/1999
Decision Date 11/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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