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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 K850298
Device Name ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM
Applicant
Cabot Medical Corp.
2021 Cabot Blvd. W.
Langhorne,  PA  19047
Applicant Contact DAVID E GRONOSTAJSK
Correspondent
Cabot Medical Corp.
2021 Cabot Blvd. W.
Langhorne,  PA  19047
Correspondent Contact DAVID E GRONOSTAJSK
Regulation Number876.4480
Classification Product Code
FEO  
Date Received01/24/1985
Decision Date 03/05/1985
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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