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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lithotriptor, Electro-Hydraulic
510(k) Number K011848
Device Name CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE
Applicant
Circon Video
6500 Hollister Ave.
Santa Barbara,  CA  93117 -3019
Applicant Contact JERRY CROUTHERS
Correspondent
Circon Video
6500 Hollister Ave.
Santa Barbara,  CA  93117 -3019
Correspondent Contact JERRY CROUTHERS
Regulation Number876.4480
Classification Product Code
FFK  
Date Received06/13/2001
Decision Date 09/11/2001
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
Predetermined Change
Control Plan Authorized		 No
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