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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K023388
Device Name MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM
Applicant
Mitek Worldwide
249 Vanderbilt Ave.
Norwood,  MA  02062
Applicant Contact PETRA C SMIT
Correspondent
Mitek Worldwide
249 Vanderbilt Ave.
Norwood,  MA  02062
Correspondent Contact PETRA C SMIT
Regulation Number888.3030
Classification Product Code
JDR  
Date Received10/09/2002
Decision Date 12/27/2002
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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