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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transilluminator, ac-powered
510(k) Number K893170
Device Name VISTA FINOFF TRANSILLUMINATOR (AC-POWERED)
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 Number886.1945
Classification Product Code
HJM  
Date Received04/25/1989
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
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