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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photostimulator, Ac-Powered
510(k) Number K914163
Device Name SCOPTOPIC SENSITIVITY TEST-1[SST-1]
Applicant
Lkc Technologies, Inc.
2 Professional Dr., Suite 222
Gaithersburg,  MD  20879
Applicant Contact JEROME LEIGHT
Correspondent
Lkc Technologies, Inc.
2 Professional Dr., Suite 222
Gaithersburg,  MD  20879
Correspondent Contact JEROME LEIGHT
Regulation Number886.1630
Classification Product Code
HLX  
Date Received09/17/1991
Decision Date 10/25/1991
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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