URETRON MODEL URT


Device Classification Name

lithotriptor, electro-hydraulic

510(k) Number K111058
Device Name URETRON MODEL URT
Applicant
MED-SONICS CORP
5451 merwin lane,
suite 203
erie, 
PA 
16510

Applicant Contact william a stoll
Correspondent
MED-SONICS CORP
5451 merwin lane,
suite 203
erie, 
PA 
16510

Correspodent Contact william a stoll
Regulation Number 876.4480
Classification Product Code
FFK  
Date Received 04/18/2011
Decision Date 03/30/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No