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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 K181094
Device Name Polydioxanone Surgical Scaffold
Applicant
Lntegra Lifesciences
1100 Campus Rd.
Princeton,  NJ  08540
Applicant Contact Kendall L. Ciriaco
Correspondent
Hogan Lovells US LLP
1735 Market St.,
23rd Floor
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number878.3300
Classification Product Code
FTL  
Date Received04/25/2018
Decision Date 08/02/2018
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
Predetermined Change
Control Plan Authorized		 No
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