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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor, eye movement
510(k) Number K872111
Device Name ORTHOTONE
Applicant
ORTHOTONE CORP.
201 EAST 28TH ST., SUITE 6-F
NEW YORK,  NY  10016
Applicant Contact JOHN ORZUCHOWSKI
Correspondent
ORTHOTONE CORP.
201 EAST 28TH ST., SUITE 6-F
NEW YORK,  NY  10016
Correspondent Contact JOHN ORZUCHOWSKI
Regulation Number886.1510
Classification Product Code
HLL  
Date Received06/01/1987
Decision Date 11/16/1988
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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