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FDA 510(k) Application Details - K152644
Device Classification Name
Tonometer, Manual
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510(K) Number
K152644
Device Name
Tonometer, Manual
Applicant
KEELER LIMITED
CLEWER HILL ROAD
WINDSOR SL4 4AA GB
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Contact
IRINA PROUTSKI
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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
09/16/2015
Decision Date
12/31/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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