TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE

Biopsy Needle

ENVISIONEERING, LLC.

The following data is part of a premarket notification filed by Envisioneering, Llc. with the FDA for Targetscan Biopsy Kit, Targetscan Biopsy Needle Guide.

Pre-market Notification Details

Device IDK073399
510k NumberK073399
Device Name:TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE
ClassificationBiopsy Needle
Applicant ENVISIONEERING, LLC. 1982 INNERBELT BUSINESS CTR DR St. Louis,  MO  63114
ContactDavid Kennedy
CorrespondentDavid Kennedy
ENVISIONEERING, LLC. 1982 INNERBELT BUSINESS CTR DR St. Louis,  MO  63114
Product CodeFCG  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-04
Decision Date2007-12-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00852656007465 K073399 000
00852656007458 K073399 000
00852656007441 K073399 000
00852656007434 K073399 000

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