LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP

Endoscopic Injection Needle, Gastroenterology-urology

LABORIE MEDICAL TECHNOLOGIES, LTD.

The following data is part of a premarket notification filed by Laborie Medical Technologies, Ltd. with the FDA for Laborie Injetak Adjustable Tip Needle, Flexible Tip And Ridgid Tip.

Pre-market Notification Details

Device IDK090830
510k NumberK090830
Device Name:LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP
ClassificationEndoscopic Injection Needle, Gastroenterology-urology
Applicant LABORIE MEDICAL TECHNOLOGIES, LTD. 400 AVENUE D SUITE 10 Williston,  VT  05495
ContactBarbara Mornet
CorrespondentBarbara Mornet
LABORIE MEDICAL TECHNOLOGIES, LTD. 400 AVENUE D SUITE 10 Williston,  VT  05495
Product CodeFBK  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-03-26
Decision Date2009-07-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20627825000028 K090830 000
20627825000011 K090830 000

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