PointerShell Universal, PointerShell LS

Ear, Nose, And Throat Stereotaxic Instrument

FIAGON GMBH

The following data is part of a premarket notification filed by Fiagon Gmbh with the FDA for Pointershell Universal, Pointershell Ls.

Pre-market Notification Details

Device IDK160479
510k NumberK160479
Device Name:PointerShell Universal, PointerShell LS
ClassificationEar, Nose, And Throat Stereotaxic Instrument
Applicant FIAGON GMBH NEUENDORFSTR. 23 B Hennigsdorf,  DE 16761
ContactDirk Mucha
CorrespondentDirk Mucha
FIAGON GMBH NEUENDORFSTR. 23 B Hennigsdorf,  DE 16761
Product CodePGW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-22
Decision Date2016-03-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EFIAE0129061 K160479 000
EFIAE0129041 K160479 000

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