WG-SURGICAL SUTURES WITH NEEDLE

Suture, Surgical, Absorbable, Polydioxanone

FOOSIN MEDICAL SUPPLIES INC.

The following data is part of a premarket notification filed by Foosin Medical Supplies Inc. with the FDA for Wg-surgical Sutures With Needle.

Pre-market Notification Details

Device IDK073614
510k NumberK073614
Device Name:WG-SURGICAL SUTURES WITH NEEDLE
ClassificationSuture, Surgical, Absorbable, Polydioxanone
Applicant FOOSIN MEDICAL SUPPLIES INC. SUITE 8D, ZHONGXIN ZHONGSHAN MANSION, NO. 19 LANE 999 Zhong Shan, Shanghai,  CN 20030
ContactDiana Hong
CorrespondentDiana Hong
FOOSIN MEDICAL SUPPLIES INC. SUITE 8D, ZHONGXIN ZHONGSHAN MANSION, NO. 19 LANE 999 Zhong Shan, Shanghai,  CN 20030
Product CodeNEW  
CFR Regulation Number878.4840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-26
Decision Date2008-04-30
Summary:summary

NIH GUDID Devices

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