LATERALASE, MODIFIED

Powered Laser Surgical Instrument

TRIMEDYNE, INC.

The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Lateralase, Modified.

Pre-market Notification Details

Device IDK944204
510k NumberK944204
Device Name:LATERALASE, MODIFIED
ClassificationPowered Laser Surgical Instrument
Applicant TRIMEDYNE, INC. 2801 BARRANCA RD. P.O. BOX 57001 Irvine,  CA  92619 -7001
ContactSusan Gamble
CorrespondentSusan Gamble
TRIMEDYNE, INC. 2801 BARRANCA RD. P.O. BOX 57001 Irvine,  CA  92619 -7001
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-12
Decision Date1994-11-28

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