LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY


Device Classification Name

device, cystometric, hydraulic

510(k) Number K073552
Device Name LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY
Applicant
LABORIE MEDICAL TECHNOLOGIES, CORP
400 ave d, ste 10
williston, 
VT 
05495

Applicant Contact barbara mornet
Correspondent
LABORIE MEDICAL TECHNOLOGIES, CORP
400 ave d, ste 10
williston, 
VT 
05495

Correspodent Contact barbara mornet
Regulation Number 876.1620
Classification Product Code
FEN  
Subsequent Product Code
EXQ  
Date Received 12/18/2007
Decision Date 03/05/2008
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