SWITCHABLE TIP SYSTEM

Powered Laser Surgical Instrument

TRIMEDYNE, INC.

The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Switchable Tip System.

Pre-market Notification Details

Device IDK923191
510k NumberK923191
Device Name:SWITCHABLE TIP SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant TRIMEDYNE, INC. 2801 BARRANCA RD. Irvine,  CA  92714 -5114
ContactPaul S Kramsky
CorrespondentPaul S Kramsky
TRIMEDYNE, INC. 2801 BARRANCA RD. Irvine,  CA  92714 -5114
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-30
Decision Date1993-03-31

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