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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue
510(k) Number K040827
Device Name PANALOK LOOP ANCHOR
Applicant
Depuy Mitek, A Johnson & Johnson Company
249 Vanderbilt Dr.
Norwood,  MA  02062
Applicant Contact ALLYSON BARFORD
Correspondent
Depuy Mitek, A Johnson & Johnson Company
249 Vanderbilt Dr.
Norwood,  MA  02062
Correspondent Contact ALLYSON BARFORD
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
GAM  
Date Received03/30/2004
Decision Date 04/30/2004
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
Recalls CDRH Recalls
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