TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER


Device Classification Name

lithotriptor, extracorporeal shock-wave,urological

510(k) Number K030346
Device Name TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
Original Applicant
FMD, LLC
p.o. box 3515
redmond, 
WA 
98073 -3515

Original Contact steven chernoff
Regulation Number 876.5990
Classification Product Code
LNS  
Date Received 02/03/2003
Decision Date 05/02/2003
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