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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, Bone
510(k) Number K021883
Device Name BIOFASTIN RC THREADED SUTURE ANCHOR
Applicant
MITEK WORLDWIDE
249 VANDERBILT AVE.
NORWOOD,  MA  02062
Applicant Contact RUTH C FORSTADT
Correspondent
MITEK WORLDWIDE
249 VANDERBILT AVE.
NORWOOD,  MA  02062
Correspondent Contact RUTH C FORSTADT
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Codes
GAM   GAS   MAI  
Date Received06/07/2002
Decision Date 07/01/2002
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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