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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 K120078
Device Name HEALIX ADVANCE BR ANCHOR
Applicant
DEPUY MITEK INC., JOHNSON AND JOHNSON COMPANY
325 Paramount Drive
Raynham,  MA  02767
Applicant Contact YAYOI FUJIMAKI
Correspondent
DEPUY MITEK INC., JOHNSON AND JOHNSON COMPANY
325 Paramount Drive
Raynham,  MA  02767
Correspondent Contact YAYOI FUJIMAKI
Regulation Number888.3030
Classification Product Code
MAI  
Date Received01/10/2012
Decision Date 02/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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