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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 K063873
Device Name ICARE TONOMETER TA01I
Applicant
TIOLAT OY
8404 SUNSTATE STREET
TAMPA,  FL  33634
Applicant Contact NELSON TOBIN
Correspondent
TIOLAT OY
8404 SUNSTATE STREET
TAMPA,  FL  33634
Correspondent Contact NELSON TOBIN
Regulation Number886.1930
Classification Product Code
HKY  
Subsequent Product Code
HKX  
Date Received12/29/2006
Decision Date 05/23/2007
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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