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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K002431
Device Name ELRAN 01 SYSTEM
Applicant
Envision Advanced Medical System, Ltd.
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Applicant Contact GERARD J PRUD'HOMME
Correspondent
Envision Advanced Medical System, Ltd.
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Correspondent Contact GERARD J PRUD'HOMME
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/08/2000
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
Predetermined Change
Control Plan Authorized		 No
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