MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS)

Instrument, Ultrasonic Surgical

MENTOR CORP.

The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Ultrasound Assisted Tissue Removal System (trs).

Pre-market Notification Details

Device IDK970471
510k NumberK970471
Device Name:MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS)
ClassificationInstrument, Ultrasonic Surgical
Applicant MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara,  CA  93111
ContactClarke Scherff
CorrespondentClarke Scherff
MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara,  CA  93111
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-02-07
Decision Date1997-07-17
Summary:summary

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