DORNIER COMPACT ALPHA LITHOTRIPTER


the company

Device Classification Name

lithotriptor, extracorporeal shock-wave,urological

510(k) Number K002929
Device Name DORNIER COMPACT ALPHA LITHOTRIPTER
Original Applicant
DORNIER MEDTECH AMERICA, INC.
1155 roberts blvd.
kennesaw, 
GA 
30144

Original Contact carol wernecke
Regulation Number 876.5990
Classification Product Code
LNS  
Date Received 09/20/2000
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