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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 K041065
Device Name PANALOK RC LOOP ANCHOR
Applicant
Depuy Mitek
249 Vanderbilt Dr.
Norwood,  MA  02062
Applicant Contact ALLYSON BARFORD
Correspondent
Depuy Mitek
249 Vanderbilt Dr.
Norwood,  MA  02062
Correspondent Contact ALLYSON BARFORD
Regulation Number888.3030
Classification Product Code
JDR  
Subsequent Product Code
MAI  
Date Received04/23/2004
Decision Date 05/07/2004
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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