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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 K180910
Device Name ULTRAPRO Mesh and ULTRAPRO ADVANCED
Applicant
Ethicon Inc
Route 22 West
P.O Box 151
Somerville,  NJ  08876
Applicant Contact Melina Escobar
Correspondent
Ethicon Inc
Route 22 West
P.O Box 151
Somerville,  NJ  08876
Correspondent Contact Melina Escobar
Regulation Number878.3300
Classification Product Code
FTL  
Date Received04/06/2018
Decision Date 07/02/2018
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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