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FDA 510(k) Application Details - K181143
Device Classification Name
Tonometer, Ac-Powered
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510(K) Number
K181143
Device Name
Tonometer, Ac-Powered
Applicant
Keeler Instruments Inc.
3222 Phoenixville Pike
Malvern, PA 19355 US
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Contact
Eugene VanArsdale
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Regulation Number
886.1930
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Classification Product Code
HKX
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More FDA Info for this Product Code
Date Received
05/01/2018
Decision Date
02/08/2019
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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