STIMULUS/DISSECTION INSTRUMENTS

Stimulator, Nerve

AXON SYSTEMS, INC.

The following data is part of a premarket notification filed by Axon Systems, Inc. with the FDA for Stimulus/dissection Instruments.

Pre-market Notification Details

Device IDK090838
510k NumberK090838
Device Name:STIMULUS/DISSECTION INSTRUMENTS
ClassificationStimulator, Nerve
Applicant AXON SYSTEMS, INC. 80-5 DAVIDS DRIVE Hauppauge,  NY  11788
ContactHoward Bailin
CorrespondentHoward Bailin
AXON SYSTEMS, INC. 80-5 DAVIDS DRIVE Hauppauge,  NY  11788
Product CodeETN  
CFR Regulation Number874.1820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-03-27
Decision Date2009-07-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994870803 K090838 000
00613994720016 K090838 000
00613994513960 K090838 000
00613994513953 K090838 000
00613994513946 K090838 000
00613994487049 K090838 000
00613994487032 K090838 000
00613994487025 K090838 000

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