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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 K842024
Device Name ULTRASONIC LITHOTRIPTOR 300A
Applicant
Fibra Sonics, Inc.
5312 N. Elston Ave.
Chicago,  IL  60630
Applicant Contact KIRCHSCHLAGER
Correspondent
Fibra Sonics, Inc.
5312 N. Elston Ave.
Chicago,  IL  60630
Correspondent Contact KIRCHSCHLAGER
Regulation Number876.4480
Classification Product Code
FEO  
Date Received05/18/1984
Decision Date 12/11/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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