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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pupillometer, ac-powered
510(k) Number K920937
Device Name COMPUTERIZED PUPIL
Applicant
TREK MEDICAL PRODUCTS, INC.
820 SWAN DR.
P.O. BOX B
MUKWONAGO,  WI  53149
Applicant Contact RONALD HUENEKE
Correspondent
TREK MEDICAL PRODUCTS, INC.
820 SWAN DR.
P.O. BOX B
MUKWONAGO,  WI  53149
Correspondent Contact RONALD HUENEKE
Regulation Number886.1700
Classification Product Code
HLG  
Date Received02/27/1992
Decision Date 10/02/1992
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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