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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 K864959
Device Name OBF MODEL 112 VACUUM CUP SYSTEM
Applicant
Ocular Blood Flow Laboratories, Inc.
9 Candlelight Ct.
Timonium,  MD  21093
Applicant Contact KENT C HOFFMAN
Correspondent
Ocular Blood Flow Laboratories, Inc.
9 Candlelight Ct.
Timonium,  MD  21093
Correspondent Contact KENT C HOFFMAN
Regulation Number886.1930
Classification Product Code
HKX  
Date Received12/18/1986
Decision Date 02/12/1987
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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