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FDA 510(k) Application Details - K063873
Device Classification Name
Tonometer, Manual
More FDA Info for this Device
510(K) Number
K063873
Device Name
Tonometer, Manual
Applicant
TIOLAT OY
8404 SUNSTATE STREET
TAMPA, FL 33634 US
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Contact
NELSON TOBIN
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Regulation Number
886.1930
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Classification Product Code
HKY
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More FDA Info for this Product Code
Date Received
12/29/2006
Decision Date
05/23/2007
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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