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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 K190316
Device Name Icare ic200
Applicant
Icare Finland Oy
Ayritie 22
Vantaa,  FI 01510
Applicant Contact Hannes Hyvonen
Correspondent
Icare Finland Oy
Ayritie 22
Vantaa,  FI 01510
Correspondent Contact Hannes Hyvonen
Regulation Number886.1930
Classification Product Code
HKY  
Date Received02/13/2019
Decision Date 01/14/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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