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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
Recalls CDRH Recalls
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