CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045


Device Classification Name

endoscope and/or accessories

510(k) Number K080613
Device Name CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045
Applicant
MINIMALLY INVASIVE DEVICES LLC
1035 waldo way
twinsburg, 
OH 
44087

Applicant Contact michael h southworth
Correspondent
MINIMALLY INVASIVE DEVICES LLC
1035 waldo way
twinsburg, 
OH 
44087

Correspodent Contact michael h southworth
Regulation Number 876.1500
Classification Product Code
KOG  
Subsequent Product Code
GCJ  
Date Received 03/04/2008
Decision Date 11/06/2008
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