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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name camera, television, endoscopic, without audio
510(k) Number K863598
Device Name VIDEO CAMERA SYSTEM
Applicant
AMERICAN EDWARDS LABORATORIES
P.O. BOX 11150
17221 RED HILL AVE.(IRVINE)
SANTA ANA,  CA  92711 -1150
Applicant Contact DIECK, PHD
Correspondent
AMERICAN EDWARDS LABORATORIES
P.O. BOX 11150
17221 RED HILL AVE.(IRVINE)
SANTA ANA,  CA  92711 -1150
Correspondent Contact DIECK, PHD
Regulation Number878.4160
Classification Product Code
FWF  
Date Received09/15/1986
Decision Date 10/02/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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