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FDA 510(k) Application Details - K093445
Device Classification Name
Tonometer, Manual
More FDA Info for this Device
510(K) Number
K093445
Device Name
Tonometer, Manual
Applicant
KEELER LTD.
456 PARKWAY
BROOMALL, PA 19008 US
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Contact
EUGENE R VANARSDALE
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
10/21/2009
Decision Date
01/19/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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