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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biomicroscope, Slit-Lamp, Ac-Powered
510(k) Number K973064
Device Name KEELER TEARSCOPE-PLUS
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 Number886.1850
Classification Product Code
HJO  
Date Received08/18/1997
Decision Date 04/07/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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