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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ophthalmoscope, ac-powered
510(k) Number K942104
Device Name KEELER VANTAGE INDIRECT OPHTHALMOSCOPE
Applicant
KEELER INSTRUMENTS, INC.
456 PKWY.
BROOMALL,  PA  19008
Applicant Contact EUGENE R VAN ARSDALE
Correspondent
KEELER INSTRUMENTS, INC.
456 PKWY.
BROOMALL,  PA  19008
Correspondent Contact EUGENE R VAN ARSDALE
Regulation Number886.1570
Classification Product Code
HLI  
Subsequent Product Code
HLJ  
Date Received05/02/1994
Decision Date 08/04/1994
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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