DIRECTVIEW, LIGHTGUIDE, MODEL(S) 10RLL-320 LAPAROSCOPE, 10DLG-320 DISPOSABLE LIGHT GUIDE FOR ABOVE


Device Classification Name

laparoscope, general & plastic surgery

510(k) Number K072613
Device Name DIRECTVIEW, LIGHTGUIDE, MODEL(S) 10RLL-320 LAPAROSCOPE, 10DLG-320 DISPOSABLE LIGHT GUIDE FOR ABOVE
Applicant
MICRO INVASIVE TECHNOLOGY INC.
934 north main st
danielson, 
CT 
06239

Applicant Contact john bala
Correspondent
MICRO INVASIVE TECHNOLOGY INC.
934 north main st
danielson, 
CT 
06239

Correspodent Contact john bala
Regulation Number 876.1500
Classification Product Code
GCJ  
Date Received 09/17/2007
Decision Date 04/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No