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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 K844323
Device Name KONAN CLINIC MICROSCOPE CLM-100-150
Applicant
Keeler Instruments, Inc.
456 Pkwy.
Broomall,  PA  19008
Applicant Contact VAN ARSDAL
Correspondent
Keeler Instruments, Inc.
456 Pkwy.
Broomall,  PA  19008
Correspondent Contact VAN ARSDAL
Regulation Number878.4700
Classification Product Code
HRM  
Date Received11/07/1984
Decision Date 11/21/1984
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
Predetermined Change
Control Plan Authorized		 No
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