DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE

Syringe, Piston

DMC MEDICAL LTD.

The following data is part of a premarket notification filed by Dmc Medical Ltd. with the FDA for Dmc Medical Single-use Polycarbonate Syringe.

Pre-market Notification Details

Device IDK103736
510k NumberK103736
Device Name:DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE
ClassificationSyringe, Piston
Applicant DMC MEDICAL LTD. 944 NORTH MAIN STREET Bountiful,  UT  84010
ContactTracy Best
CorrespondentTracy Best
DMC MEDICAL LTD. 944 NORTH MAIN STREET Bountiful,  UT  84010
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-22
Decision Date2011-06-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B1605020Y1 K103736 000
40193489954242 K103736 000
G002100630 K103736 000
G002100170 K103736 000
G002100350 K103736 000
G002100360 K103736 000
G001ZSQ1W0 K103736 000
B1605020B1 K103736 000
B1605003Y1 K103736 000
B1605006B1 K103736 000
40193489957571 K103736 000

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