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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Eyelid, Ophthalmic
510(k) Number K891610
Device Name HENSON CFA 3000 CENTRAL VISUAL FIELD SCREENER
Applicant
Keeler Instruments, Inc.
456 Pkwy.
Broomall,  PA  19008
Applicant Contact VAN ARSDALE
Correspondent
Keeler Instruments, Inc.
456 Pkwy.
Broomall,  PA  19008
Correspondent Contact VAN ARSDALE
Regulation Number886.4350
Classification Product Code
HOD  
Date Received03/20/1989
Decision Date 06/05/1989
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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