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FDA 510(k) Application Details - K152308
Device Classification Name
Tonometer, Manual
More FDA Info for this Device
510(K) Number
K152308
Device Name
Tonometer, Manual
Applicant
SENSOR MEDICAL TECHNOLOGY, LLC
23175 224th Place SE
Maple Valley, WA 98038 US
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Contact
Louise Culham
Other 510(k) Applications for this Contact
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
08/14/2015
Decision Date
10/13/2015
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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