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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 K873422
Device Name OBF MODEL 115 COMPUTER TONOMETER SYSTEM
Applicant
OCULAR BLOOD FLOW LABORATORIES, INC.
9 CANDLELIGHT COURT
TIMONIUM,  MD  21093
Applicant Contact KENT C HOFFMAN
Correspondent
OCULAR BLOOD FLOW LABORATORIES, INC.
9 CANDLELIGHT COURT
TIMONIUM,  MD  21093
Correspondent Contact KENT C HOFFMAN
Regulation Number886.1930
Classification Product Code
HKX  
Date Received08/26/1987
Decision Date 11/02/1987
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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