ULTRA Telescopes

Nasopharyngoscope (flexible Or Rigid)

OLYMPUS, WINTER & IBE GMBH

The following data is part of a premarket notification filed by Olympus, Winter & Ibe Gmbh with the FDA for Ultra Telescopes.

Pre-market Notification Details

Device IDK153009
510k NumberK153009
Device Name:ULTRA Telescopes
ClassificationNasopharyngoscope (flexible Or Rigid)
Applicant OLYMPUS, WINTER & IBE GMBH KUEHNSTR. 61 Hamburg,  DE 22045
ContactKatharina Schnackenburg
CorrespondentSheri L. Musgnung
OLYMPUS CORPORATION OF THE AMERICAS 3500 CORPORATE PARKWAY Center Valley,  PA  18034
Product CodeEOB  
CFR Regulation Number874.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-10-14
Decision Date2016-04-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04042761083096 K153009 000
04042761083089 K153009 000
04042761083072 K153009 000
04042761083065 K153009 000
04042761083058 K153009 000
04042761083041 K153009 000
04042761083034 K153009 000

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