SYNTHETIC ABSORBABLE SUTURE

Suture, Absorbable, Synthetic, Polyglycolic Acid

FOOSIN MEDICAL SUPPLIES INC.LTD

The following data is part of a premarket notification filed by Foosin Medical Supplies Inc.ltd with the FDA for Synthetic Absorbable Suture.

Pre-market Notification Details

Device IDK130737
510k NumberK130737
Device Name:SYNTHETIC ABSORBABLE SUTURE
ClassificationSuture, Absorbable, Synthetic, Polyglycolic Acid
Applicant FOOSIN MEDICAL SUPPLIES INC.LTD PO BOX 120-119 Shanghai,  CN 200120
ContactDiana Hong
CorrespondentDiana Hong
FOOSIN MEDICAL SUPPLIES INC.LTD PO BOX 120-119 Shanghai,  CN 200120
Product CodeGAM  
CFR Regulation Number878.4493 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-18
Decision Date2014-01-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20814639022968 K130737 000
00840118611336 K130737 000
00840118614740 K130737 000
10814639026105 K130737 000
10814639025535 K130737 000
10814639025542 K130737 000
10814639024873 K130737 000
B031MVY3440 K130737 000
B031MVY3450 K130737 000
B031MVY3460 K130737 000
B031MVY9220 K130737 000
B031MVY9230 K130737 000
B031MVY9420 K130737 000
B031MVY9430 K130737 000
B031MVY9670 K130737 000
B031MVY9870 K130737 000
00817169021131 K130737 000
00840118611329 K130737 000

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