TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY 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 Surguard3 Safety Needle & Hypodermic Syringe With Safety Needle.

Pre-market Notification Details

Device IDK122249
510k NumberK122249
Device Name:TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE
ClassificationNeedle, Hypodermic, Single Lumen
Applicant TERUMO (PHILIPPINES) CORPORATION 950 ELKTON BLVD Elkton,  MD  21921
ContactPhillip Lester
CorrespondentPhillip Lester
TERUMO (PHILIPPINES) CORPORATION 950 ELKTON BLVD Elkton,  MD  21921
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-27
Decision Date2012-08-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
54806017511765 K122249 000
54806017508192 K122249 000
54806017508178 K122249 000
34806017509720 K122249 000
34806017509713 K122249 000
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54806017509694 K122249 000
34806017509263 K122249 000
54806017509250 K122249 000
54806017508208 K122249 000
54806017508222 K122249 000
54806017508512 K122249 000
54806017508444 K122249 000
54806017508437 K122249 000
54806017508420 K122249 000
54806017508413 K122249 000
54806017508253 K122249 000
54806017508246 K122249 000
54806017508239 K122249 000
54806017509236 K122249 000

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