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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 K882750
Device Name OCU-FILM TIP COVER
Applicant
Oculab, Inc.
443 W. Colorado St.
Gendale,  CA  91204
Applicant Contact BRUCE BURR
Correspondent
Oculab, Inc.
443 W. Colorado St.
Gendale,  CA  91204
Correspondent Contact BRUCE BURR
Regulation Number886.1930
Classification Product Code
HKY  
Date Received07/05/1988
Decision Date 08/04/1988
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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