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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 PARKWAY
BROOMALL,  PA  19008
Applicant Contact EUGENE R VANARSDALE
Correspondent
KEELER LTD.
456 PARKWAY
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
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