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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 K163343
Device Name Icare HOME tonometer
Applicant
Icare Finland Oy
Ayritie 22
Vantaa,  FI 01510
Applicant Contact Matti Tulikoura
Correspondent
DuVal & Associates, P.A.
1820 Medical Arts Building, 825 Nicollet Mall
Minneapolis,  MN  55402
Correspondent Contact Mark DuVal
Regulation Number886.1930
Classification Product Code
HKY  
Subsequent Product Code
HKX  
Date Received11/29/2016
Decision Date 03/21/2017
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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