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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K013781
Device Name RIDIDFIX 2.7MM BTB CROSS PIN KIT
Applicant
Mitek Products
249 Vanderbilt Ave.
Norwood,  MA  02062
Applicant Contact JENNIFER JOHNSON
Correspondent
Mitek Products
249 Vanderbilt Ave.
Norwood,  MA  02062
Correspondent Contact JENNIFER JOHNSON
Regulation Number888.3040
Classification Product Code
HTY  
Subsequent Product Code
MAI  
Date Received11/14/2001
Decision Date 02/06/2002
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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