LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS

Retractor

LUXTEC CORP.

The following data is part of a premarket notification filed by Luxtec Corp. with the FDA for Luxtec Retractors, Luxtec Specialty Retractors.

Pre-market Notification Details

Device IDK864384
510k NumberK864384
Device Name:LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS
ClassificationRetractor
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 CodeGAD  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-11-05
Decision Date1986-11-19

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