NASO-LARYNGO-PHARYNGOSCOPE

Nasopharyngoscope (flexible Or Rigid)

FIBER IMAGING TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Fiber Imaging Technologies, Inc. with the FDA for Naso-laryngo-pharyngoscope.

Pre-market Notification Details

Device IDK991560
510k NumberK991560
Device Name:NASO-LARYNGO-PHARYNGOSCOPE
ClassificationNasopharyngoscope (flexible Or Rigid)
Applicant FIBER IMAGING TECHNOLOGIES, INC. 45 PONTIAC RD. Newton,  MA  02468
ContactJoseph Ress
CorrespondentJoseph Ress
FIBER IMAGING TECHNOLOGIES, INC. 45 PONTIAC RD. Newton,  MA  02468
Product CodeEOB  
CFR Regulation Number874.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-04
Decision Date1999-07-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994455383 K991560 000
00885074017747 K991560 000

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