FDA 510(k) Application Details - K143205

Device Classification Name Pump, Infusion, Ophthalmic

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510(K) Number K143205
Device Name Pump, Infusion, Ophthalmic
Applicant Sight Sciences, Inc.
3000 Sand Hill Road, Building 3
Suite 105
Menlo Park, CA 94025 US
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Contact Paul Badawl
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Regulation Number 880.5725

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Classification Product Code MRH
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Date Received 11/07/2014
Decision Date 12/05/2014
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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