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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tonometer, Manual
510(k) Number K093445
Device Name KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT)
Applicant
Keeler, Ltd.
456 Pkwy.
Broomall,  PA  19008
Applicant Contact EUGENE R VANARSDALE
Correspondent
Keeler, Ltd.
456 Pkwy.
Broomall,  PA  19008
Correspondent Contact EUGENE R VANARSDALE
Regulation Number886.1930
Classification Product Code
HKY  
Date Received10/21/2009
Decision Date 01/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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