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FDA 510(k) Application Details - K173904
Device Classification Name
Tonometer, Manual
More FDA Info for this Device
510(K) Number
K173904
Device Name
Tonometer, Manual
Applicant
CATS Tonometer, LLC
1517 N. Wilmot, Suite 143
Tucson, AZ 85712 US
Other 510(k) Applications for this Company
Contact
Sean J. McCafferty
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
12/22/2017
Decision Date
03/09/2018
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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