SIGHTSURE OPERATIONAL INDICATOR, MODEL SS301


Device Classification Name

tubes, gastrointestinal (and accessories)

510(k) Number K072550
Device Name SIGHTSURE OPERATIONAL INDICATOR, MODEL SS301
Applicant
MEDEVICE, INC.
p.o. box 848
grayslake, 
IL 
60030

Applicant Contact michele h vovolka
Correspondent
MEDEVICE, INC.
p.o. box 848
grayslake, 
IL 
60030

Correspodent Contact michele h vovolka
Regulation Number 876.5980
Classification Product Code
KNT  
Date Received 09/10/2007
Decision Date 12/07/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No