RESPOSABLE BARE FIBERS

Powered Laser Surgical Instrument

TRIMEDYNE, INC.

The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Resposable Bare Fibers.

Pre-market Notification Details

Device IDK973172
510k NumberK973172
Device Name:RESPOSABLE BARE FIBERS
ClassificationPowered Laser Surgical Instrument
Applicant TRIMEDYNE, INC. 2801 BARRANCA RD. P.O. BOX 57001 Irvine,  CA  92619 -7001
ContactSusan H Gamble
CorrespondentSusan H 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 Received1997-08-25
Decision Date1998-02-03
Summary:summary

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