TERUMO(R) NEEDLE

Needle, Hypodermic, Single Lumen

TERUMO (PHILIPPINES) CORPORATION

The following data is part of a premarket notification filed by Terumo (philippines) Corporation with the FDA for Terumo(r) Needle.

Pre-market Notification Details

Device IDK121607
510k NumberK121607
Device Name:TERUMO(R) NEEDLE
ClassificationNeedle, Hypodermic, Single Lumen
Applicant TERUMO (PHILIPPINES) CORPORATION 950 ELKTON BLVD Elkton,  MD  21921
ContactSandi Hartka
CorrespondentSandi Hartka
TERUMO (PHILIPPINES) CORPORATION 950 ELKTON BLVD Elkton,  MD  21921
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-06-01
Decision Date2012-11-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
54806017512045 K121607 000
74806017511929 K121607 000
54806017511918 K121607 000
54806017511901 K121607 000
54806017511895 K121607 000
54806017511888 K121607 000
74806017511875 K121607 000
54806017511864 K121607 000
54806017511857 K121607 000
74806017511844 K121607 000
74806017511936 K121607 000
74806017511943 K121607 000
54806017512038 K121607 000
54806017512021 K121607 000
74806017512018 K121607 000
74806017512001 K121607 000
74806017511998 K121607 000
74806017511981 K121607 000
74806017511974 K121607 000
74806017511967 K121607 000
54806017511956 K121607 000
74806017511837 K121607 000

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