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FDA 510(k) Application Details - K163343
Device Classification Name
Tonometer, Manual
More FDA Info for this Device
510(K) Number
K163343
Device Name
Tonometer, Manual
Applicant
Icare Finland Oy
Ayritie 22
Vantaa 01510 FI
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Contact
Matti Tulikoura
Other 510(k) Applications for this Contact
Regulation Number
886.1930
More FDA Info for this Regulation Number
Classification Product Code
HKY
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More FDA Info for this Product Code
Date Received
11/29/2016
Decision Date
03/21/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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