STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES

Stimulator, Nerve

MEDTRONIC XOMED, INC.

The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Stimulus/dissection Instruments, Ball-tip Probes.

Pre-market Notification Details

Device IDK031003
510k NumberK031003
Device Name:STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES
ClassificationStimulator, Nerve
Applicant MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216
ContactMartin D Sargent
CorrespondentMartin D Sargent
MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216
Product CodeETN  
CFR Regulation Number874.1820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-31
Decision Date2003-04-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994131645 K031003 000
00885074101347 K031003 000
00885074101361 K031003 000
00885074286341 K031003 000
00763000036324 K031003 000
00763000036331 K031003 000
00763000036690 K031003 000
00721902572654 K031003 000
00721902572715 K031003 000
00721902600951 K031003 000
00721902670756 K031003 000
00721902670763 K031003 000
20721902572702 K031003 000

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