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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lithotriptor, ultrasonic
510(k) Number K993046
Device Name FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000
Applicant
FIBRA SONICS, INC.
5312 N. ELSTON AVE.
CHICAGO,  IL  60630
Applicant Contact ROBERT BROHM
Correspondent
FIBRA SONICS, INC.
5312 N. ELSTON AVE.
CHICAGO,  IL  60630
Correspondent Contact ROBERT BROHM
Regulation Number876.4480
Classification Product Code
FEO  
Date Received09/10/1999
Decision Date 11/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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