FDA 510(k) Application Details - K201953

Device Classification Name Pump, Infusion, Ophthalmic

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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
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Regulation Number 880.5725

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Classification Product Code MRH
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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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