LUXTEC, KILLIAN AND VIENNA NASAL SPECULUMS

Source, Carrier, Fiberoptic Light

LUXTEC CORP.

The following data is part of a premarket notification filed by Luxtec Corp. with the FDA for Luxtec, Killian And Vienna Nasal Speculums.

Pre-market Notification Details

Device IDK864383
510k NumberK864383
Device Name:LUXTEC, KILLIAN AND VIENNA NASAL SPECULUMS
ClassificationSource, Carrier, Fiberoptic Light
Applicant LUXTEC CORP. P.O. BOX 225, RTE 20/49 TECHNO PARK RD Sturbridge,  MA  01566
ContactThomas Wilk
CorrespondentThomas Wilk
LUXTEC CORP. P.O. BOX 225, RTE 20/49 TECHNO PARK RD Sturbridge,  MA  01566
Product CodeEQH  
CFR Regulation Number874.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-11-05
Decision Date1987-01-14

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