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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lens, fundus, hruby, diagnostic
510(k) Number K897186
Device Name LASER IMAGING WORK STATION
Applicant
INNOVISION MEDICAL, INC.
P.O. BOX 40813
WASHINGTON,  DC  20016
Applicant Contact L MACKEEN,PHD
Correspondent
INNOVISION MEDICAL, INC.
P.O. BOX 40813
WASHINGTON,  DC  20016
Correspondent Contact L MACKEEN,PHD
Regulation Number886.1395
Classification Product Code
HJI  
Date Received12/28/1989
Decision Date 03/12/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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