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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Instrument, Manual, Ophthalmic
510(k) Number K842410
Device Name AMER. EDWARDS LAB FLEXISCOPE
Applicant
American Edwards Laboratories
P.O. Box 11150
17221 Red Hill Ave.(Irvine)
Santa Ana,  CA  92711
Applicant Contact RONALD J EHMSEN
Correspondent
American Edwards Laboratories
P.O. Box 11150
17221 Red Hill Ave.(Irvine)
Santa Ana,  CA  92711
Correspondent Contact RONALD J EHMSEN
Regulation Number886.4855
Classification Product Code
HRK  
Date Received06/19/1984
Decision Date 11/05/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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