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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tonometer, Ac-Powered
510(k) Number K843354
Device Name EPISCLERAL VENOUS PRESSURE
Applicant
Eyetech, LLC
2042 W. Farragut Ave.
Chicago,  IL  60625
Applicant Contact MAREK T MORI
Correspondent
Eyetech, LLC
2042 W. Farragut Ave.
Chicago,  IL  60625
Correspondent Contact MAREK T MORI
Regulation Number886.1930
Classification Product Code
HKX  
Date Received08/27/1984
Decision Date 11/19/1984
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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