ULTRAPRO Mesh And ULTRAPRO ADVANCED

Mesh, Surgical, Polymeric

Ethicon Inc

The following data is part of a premarket notification filed by Ethicon Inc with the FDA for Ultrapro Mesh And Ultrapro Advanced.

Pre-market Notification Details

Device IDK180910
510k NumberK180910
Device Name:ULTRAPRO Mesh And ULTRAPRO ADVANCED
ClassificationMesh, Surgical, Polymeric
Applicant Ethicon Inc Route 22 West P.O Box 151 Somerville,  NJ  08876
ContactMelina Escobar
CorrespondentMelina Escobar
Ethicon Inc Route 22 West P.O Box 151 Somerville,  NJ  08876
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-06
Decision Date2018-07-02

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