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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 K150906
FOIA Releasable 510(k) K150906
Device Name ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh
Applicant
EHICON INC.
ROUTE22 WEST, P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
Applicant Contact SUSAN LIN
Correspondent
ELTHICON INC.
ROUTE22 WEST, P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
Correspondent Contact SUSAN LIN
Regulation Number878.3300
Classification Product Code
FTL  
Date Received04/03/2015
Decision Date 07/24/2015
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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