FDA 510(k) Application Details - K192620

Device Classification Name

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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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