XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT

Nasopharyngoscope (flexible Or Rigid)

THE OLYMPUS OPTICAL CO.

The following data is part of a premarket notification filed by The Olympus Optical Co. with the FDA for Xenf-dp Rhino-laryngofiberscope, Its Accessories And Ancillary Equipment.

Pre-market Notification Details

Device IDK011869
510k NumberK011869
Device Name:XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
ClassificationNasopharyngoscope (flexible Or Rigid)
Applicant THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville,  NY  11747
ContactLaura Storms-tyler
CorrespondentLaura Storms-tyler
THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville,  NY  11747
Product CodeEOB  
CFR Regulation Number874.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-06-14
Decision Date2001-07-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170318221 K011869 000
04953170411335 K011869 000
04953170411052 K011869 000
04953170411069 K011869 000
04953170050992 K011869 000
04953170059018 K011869 000
04953170059032 K011869 000
04953170071683 K011869 000
04953170078231 K011869 000
04953170307188 K011869 000
04953170318191 K011869 000
04953170318207 K011869 000
04953170318214 K011869 000
04953170411076 K011869 000

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