RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE)

Powered Laser Surgical Instrument

TRIMEDYNE, INC.

The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Resposable Omni Tip(tm) Switchable Tips (multiple).

Pre-market Notification Details

Device IDK964585
510k NumberK964585
Device Name:RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE)
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 Received1996-11-15
Decision Date1997-04-17
Summary:summary

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