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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tonometer, manual
510(k) Number K852774
Device Name OCULAB TONOPEN
Applicant
OCULAB, INC.
443 WEST COLORADO ST.
GENDALE,  CA  91204
Applicant Contact DAVID A WALLACE
Correspondent
OCULAB, INC.
443 WEST COLORADO ST.
GENDALE,  CA  91204
Correspondent Contact DAVID A WALLACE
Regulation Number886.1930
Classification Product Code
HKY  
Date Received07/01/1985
Decision Date 08/20/1985
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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