ULTRASONIC LITHOTRIPTOR 300A

Lithotriptor, Ultrasonic

FIBRA SONICS, INC.

The following data is part of a premarket notification filed by Fibra Sonics, Inc. with the FDA for Ultrasonic Lithotriptor 300a.

Pre-market Notification Details

Device IDK842024
510k NumberK842024
Device Name:ULTRASONIC LITHOTRIPTOR 300A
ClassificationLithotriptor, Ultrasonic
Applicant FIBRA SONICS, INC. 5312 N. ELSTON AVE. Chicago,  IL  60630
ContactKirchschlager
CorrespondentKirchschlager
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 Received1984-05-18
Decision Date1984-12-11

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