J+PRAS YOUNG'S Thread

Suture, Surgical, Absorbable, Polydioxanone

Y. Jacobs Medical, Inc.

The following data is part of a premarket notification filed by Y. Jacobs Medical, Inc. with the FDA for J+pras Young's Thread.

Pre-market Notification Details

Device IDK143413
510k NumberK143413
Device Name:J+PRAS YOUNG'S Thread
ClassificationSuture, Surgical, Absorbable, Polydioxanone
Applicant Y. Jacobs Medical, Inc. 6F Sangkyeong Bldg. 669 Seolleung-ro, Gangnam-gu Seoul,  KR 135830
ContactJoo Hwan Jeon
CorrespondentMeredith May
Qserve Group US Inc. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeNEW  
CFR Regulation Number878.4840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-28
Decision Date2015-09-11

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