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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 K980492
Device Name AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)
Applicant
Circon Acmi
300 Stillwater Ave.
P.O. Box 1971
Stamford,  CT  06904
Applicant Contact RONALD J EHMSEN
Correspondent
Circon Acmi
300 Stillwater Ave.
P.O. Box 1971
Stamford,  CT  06904
Correspondent Contact RONALD J EHMSEN
Regulation Number876.4480
Classification Product Code
FFK  
Date Received02/09/1998
Decision Date 11/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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