9105 RIGID TELESCOPIC ENDOSCOPE

Laryngostroboscope

KAY ELEMETRICS CORP.

The following data is part of a premarket notification filed by Kay Elemetrics Corp. with the FDA for 9105 Rigid Telescopic Endoscope.

Pre-market Notification Details

Device IDK921285
510k NumberK921285
Device Name:9105 RIGID TELESCOPIC ENDOSCOPE
ClassificationLaryngostroboscope
Applicant KAY ELEMETRICS CORP. 12 MAPLE AVE. P.O. BOX 2025 Pine Brook,  NJ  07058
ContactWilliam Harbeson
CorrespondentWilliam Harbeson
KAY ELEMETRICS CORP. 12 MAPLE AVE. P.O. BOX 2025 Pine Brook,  NJ  07058
Product CodeEQL  
CFR Regulation Number874.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-17
Decision Date1992-05-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04961333240692 K921285 000
04961333240586 K921285 000
04961333240579 K921285 000
04961333240562 K921285 000
04961333240548 K921285 000
04961333240531 K921285 000

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