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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 K133234
Device Name T-TYPE D-KAT, R-TYPE D-KAT
Applicant
KEELER LIMITED
456 PARKWAY
BROOMALL,  PA  19008
Applicant Contact EUGENE R VANARSDALE
Correspondent
KEELER LIMITED
456 PARKWAY
BROOMALL,  PA  19008
Correspondent Contact EUGENE R VANARSDALE
Regulation Number886.1930
Classification Product Code
HKY  
Date Received10/21/2013
Decision Date 02/21/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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