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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 K142192
Device Name Insightra Freedom Ventral Hernia Repair System
Applicant
Insightra Medical
9200 Irvine Center Drive
Suite 200
Irvine,  CA  92618
Applicant Contact Neerav Parikh
Correspondent
Insightra Medical
9200 Irvine Center Drive
Suite 200
Irvine,  CA  92618
Correspondent Contact Neerav Parikh
Regulation Number878.3300
Classification Product Code
FTL  
Subsequent Product Code
OXJ  
Date Received08/11/2014
Decision Date 05/07/2015
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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