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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Special Lens, For Endoscope
510(k) Number K862872
Device Name FLEXIBLE VISUALIZATION CATHETER
Applicant
AMERICAN EDWARDS LABORATORIES
P.O. BOX 11150
17221 RED HILL AVE.(IRVINE)
SANTA ANA,  CA  92711 -1150
Applicant Contact COLE, PH.D.
Correspondent
AMERICAN EDWARDS LABORATORIES
P.O. BOX 11150
17221 RED HILL AVE.(IRVINE)
SANTA ANA,  CA  92711 -1150
Correspondent Contact COLE, PH.D.
Regulation Number876.1500
Classification Product Code
FEI  
Date Received07/30/1986
Decision Date 10/24/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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