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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name microscope, operating & accessories, ac-powered, ophthalmic
510(k) Number K914956
Device Name KEELER KONAN SPECULAR MICROSCOPE SP5500
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 Number878.4700
Classification Product Code
HRM  
Date Received11/05/1991
Decision Date 02/03/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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