MICRONJET 600

Needle, Hypodermic, Single Lumen

NANOPASS TECHNOLOGIES LTD.

The following data is part of a premarket notification filed by Nanopass Technologies Ltd. with the FDA for Micronjet 600.

Pre-market Notification Details

Device IDK092746
510k NumberK092746
Device Name:MICRONJET 600
ClassificationNeedle, Hypodermic, Single Lumen
Applicant NANOPASS TECHNOLOGIES LTD. 555 13TH ST. NW Washington,  DC  20004
ContactJonathan Kahan
CorrespondentJonathan Kahan
NANOPASS TECHNOLOGIES LTD. 555 13TH ST. NW Washington,  DC  20004
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-08
Decision Date2010-02-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17290015928080 K092746 000
17290015928035 K092746 000
17290015928011 K092746 000
17290015928226 K092746 000
17290015928271 K092746 000
17290015928257 K092746 000

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