3S Safety Syringe With/without Needle

Syringe, Antistick

Sincere Medical Device Co., Ltd.

The following data is part of a premarket notification filed by Sincere Medical Device Co., Ltd. with the FDA for 3s Safety Syringe With/without Needle.

Pre-market Notification Details

Device IDK142435
510k NumberK142435
Device Name:3S Safety Syringe With/without Needle
ClassificationSyringe, Antistick
Applicant Sincere Medical Device Co., Ltd. Rm 218, 2F., No.183, Zhouzi St. Taipei,  TW 114
ContactGarfield Wang
CorrespondentGarfield Wang
Sincere Medical Device Co., Ltd. Rm 218, 2F., No.183, Zhouzi St. Taipei,  TW 114
Product CodeMEG  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-29
Decision Date2015-02-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
G018SY03LL0214 K142435 000
G018SY01LL0212 K142435 000

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