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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
Applicant Contact JERRY CROUTHERS
Correspondent
Circon Video
6500 Hollister Ave.
Santa Barbara,  CA  93117
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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