LUXTEC ACO SERIES 4000 LIGHT SOURCE

Light Source, Fiberoptic, Routine

LUXTEC CORP.

The following data is part of a premarket notification filed by Luxtec Corp. with the FDA for Luxtec Aco Series 4000 Light Source.

Pre-market Notification Details

Device IDK890716
510k NumberK890716
Device Name:LUXTEC ACO SERIES 4000 LIGHT SOURCE
ClassificationLight Source, Fiberoptic, Routine
Applicant LUXTEC CORP. P.O. BOX 225, RTE 20/49 TECHNO PARK RD Sturbridge,  MA  01566
ContactBruce K Packard
CorrespondentBruce K Packard
LUXTEC CORP. P.O. BOX 225, RTE 20/49 TECHNO PARK RD Sturbridge,  MA  01566
Product CodeFCW  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-02-13
Decision Date1989-04-26

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