Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,

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 Y.jacobs Young's Thread Synthetic Absorbable Surgical Fixation Suture,.

Pre-market Notification Details

Device IDK160705
510k NumberK160705
Device Name:Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,
ClassificationSuture, Surgical, Absorbable, Polydioxanone
Applicant Y. JACOBS MEDICAL, INC 6F SANGKYUNG BLDG. 669 SEOLLEUNG-RO GANGNAM-GU Seoul,  KR 135-830
ContactHui Jun Park
CorrespondentMeredith May
EMPIRICAL TESTING 4628 NORTHPARK DRIVE Colorado Springs,  CO  80918
Product CodeNEW  
CFR Regulation Number878.4840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-14
Decision Date2016-11-23
Summary:summary

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