ELRAN 01 SYSTEM


the company

Device Classification Name

laparoscope, general & plastic surgery

510(k) Number K002431
Device Name ELRAN 01 SYSTEM
Original Applicant
ENVISION ADVANCED MEDICAL SYSTEM LTD
555 thirteenth street, n.w.
washington, 
DC 
20004 -1109

Original Contact gerard j prud’homme
Regulation Number 876.1500
Classification Product Code
GCJ  
Date Received 08/08/2000
Decision Date 10/24/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

Type Abbreviated
Reviewed by Third Party No

Combination Product

No