FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000

Lithotriptor, Ultrasonic

FIBRA SONICS, INC.

The following data is part of a premarket notification filed by Fibra Sonics, Inc. with the FDA for Fibra Sonics Ultrasonic Lithotriptor Lithosonic, Model Ls-2000.

Pre-market Notification Details

Device IDK993046
510k NumberK993046
Device Name:FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000
ClassificationLithotriptor, Ultrasonic
Applicant FIBRA SONICS, INC. 5312 N. ELSTON AVE. Chicago,  IL  60630
ContactRobert Brohm
CorrespondentRobert Brohm
FIBRA SONICS, INC. 5312 N. ELSTON AVE. Chicago,  IL  60630
Product CodeFEO  
CFR Regulation Number876.4480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-09-10
Decision Date1999-11-22

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