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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 K113552
Device Name FREEDOM INGUINAL HERNIA IMPLANT
Applicant
Insightra Medical
9200 IRVINE CENTER DR
SUITE 200
IRVINE,  CA  92618
Applicant Contact Wayne Noda
Correspondent
Insightra Medical
9200 IRVINE CENTER DR
SUITE 200
IRVINE,  CA  92618
Correspondent Contact Wayne Noda
Regulation Number878.3300
Classification Product Code
FTL  
Date Received12/01/2011
Decision Date 08/23/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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