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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 K012445
Device Name EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)
Applicant
ELECTRO MEDICAL SYSTEMS SA
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact SHEILA HEMEON-HEYER
Correspondent
ELECTRO MEDICAL SYSTEMS SA
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact SHEILA HEMEON-HEYER
Regulation Number876.4480
Classification Product Code
FFK  
Date Received08/01/2001
Decision Date 08/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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