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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name perimeter, ac-powered
510(k) Number K864467
Device Name HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN
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 Number886.1605
Classification Product Code
HOO  
Date Received11/12/1986
Decision Date 12/15/1986
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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