DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR

Staple, Implantable

CHANGZHOU SINOLINKS MEDICAL INNOVATION CO., LTD

The following data is part of a premarket notification filed by Changzhou Sinolinks Medical Innovation Co., Ltd with the FDA for Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear Staplers And Reloads, Disposable Hemorr.

Pre-market Notification Details

Device IDK131511
510k NumberK131511
Device Name:DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR
ClassificationStaple, Implantable
Applicant CHANGZHOU SINOLINKS MEDICAL INNOVATION CO., LTD P.O. BOX 120-119 Shanghai,  CN 200120
ContactDiana Hong
CorrespondentDiana Hong
CHANGZHOU SINOLINKS MEDICAL INNOVATION CO., LTD P.O. BOX 120-119 Shanghai,  CN 200120
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-28
Decision Date2013-07-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06946480589373 K131511 000
06946480589366 K131511 000
06946480589311 K131511 000
06946480576151 K131511 000
06946480576052 K131511 000
06946480563632 K131511 000
06946480510537 K131511 000
06946480503638 K131511 000
06946480501276 K131511 000

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