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FDA 510(k) Application Details - K192620
Device Classification Name
More FDA Info for this Device
510(K) Number
K192620
Device Name
SNA-001 Silver Photoparticle Topical Gel
Applicant
Sienna Biopharmaceuticals, Inc.
30699 Russell Ranch Road, Suite 140
Westlake Village, CA 91362 US
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Contact
Paul Lizzul
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Regulation Number
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Classification Product Code
QCY
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Date Received
09/23/2019
Decision Date
08/12/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K192620
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