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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical, polymeric
510(k) Number K140967
Device Name FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK
Applicant
Insightra Medical
9200 IRVINE CENTER DR
SUITE 200
IRVINE,  CA  92618
Applicant Contact LISA MALONEY
Correspondent
Insightra Medical
9200 IRVINE CENTER DR
SUITE 200
IRVINE,  CA  92618
Correspondent Contact LISA MALONEY
Regulation Number878.3300
Classification Product Code
FTL  
Date Received04/14/2014
Decision Date 06/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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