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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 K002929
Device Name DORNIER COMPACT ALPHA LITHOTRIPTER
Applicant
DORNIER MEDTECH AMERICA, INC.
1155 ROBERTS BLVD.
KENNESAW,  GA  30144
Applicant Contact CAROL WERNECKE
Correspondent
DORNIER MEDTECH AMERICA, INC.
1155 ROBERTS BLVD.
KENNESAW,  GA  30144
Correspondent Contact CAROL WERNECKE
Regulation Number876.5990
Classification Product Code
LNS  
Date Received09/20/2000
Decision Date 04/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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