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FDA 510(k) Application Details - K201953
Device Classification Name
Pump, Infusion, Ophthalmic
More FDA Info for this Device
510(K) Number
K201953
Device Name
Pump, Infusion, Ophthalmic
Applicant
Sight Sciences, Inc.
4040 Campbell Ave., Suite 100
Menlo Park, CA 94025 US
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Contact
Edward J. Sinclair
Other 510(k) Applications for this Contact
Regulation Number
880.5725
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Classification Product Code
MRH
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More FDA Info for this Product Code
Date Received
07/14/2020
Decision Date
08/11/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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