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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lithotriptor, Extracorporeal Shock-Wave, Urological
510(k) Number K011873
Device Name DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP)
Applicant
DORNIER
1155 ROBERTS BLVD.
KENNESAW,  GA  30144
Applicant Contact SUZANNEW COURTNEY
Correspondent
DORNIER
1155 ROBERTS BLVD.
KENNESAW,  GA  30144
Correspondent Contact SUZANNEW COURTNEY
Regulation Number876.5990
Classification Product Code
LNS  
Date Received06/15/2001
Decision Date 08/31/2001
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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