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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name telescope, spectacle, low-vision
510(k) Number K870203
Device Name KEELER LVA SYSTEM MULTI-CAP SERIES LVA51-1/2/3/4/5
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 Number886.5870
Classification Product Code
HKK  
Date Received01/20/1987
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
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