RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE

Neurological Stereotaxic Instrument

RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP

The following data is part of a premarket notification filed by Radionics, A Division Of Tyco Healthcare Group Lp with the FDA for Radionics Nashold Biopsy Needle - Single Use.

Pre-market Notification Details

Device IDK032054
510k NumberK032054
Device Name:RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE
ClassificationNeurological Stereotaxic Instrument
Applicant RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP 22 TERRY AVE. Burlington,  MA  01803
ContactKevin J O'connell
CorrespondentKevin J O'connell
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP 22 TERRY AVE. Burlington,  MA  01803
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-07-02
Decision Date2003-09-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M248CRWBP1 K032054 000
M248RTNBND761 K032054 000
M248RTNBND1161 K032054 000
M248GT271601 K032054 000
M248GT321161 K032054 000
M433GT321601 K032054 000
M248GT32761 K032054 000
M433GT461161 K032054 000
M433RTNBND1601 K032054 000
30381780252591 K032054 000
M248NBND1 K032054 000

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