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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 K123038
Device Name SWISS LITHOBREAKER
Applicant
E.M.S Electro Medical Systems S.A
225 Tpke. Rd.
Southbrough,  MA  01772
Applicant Contact SUZANNE GOODMAN
Correspondent
E.M.S Electro Medical Systems S.A
225 Tpke. Rd.
Southbrough,  MA  01772
Correspondent Contact SUZANNE GOODMAN
Regulation Number876.4480
Classification Product Code
FFK  
Date Received09/28/2012
Decision Date 01/16/2013
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
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