FDA 510(k)

SNA-001 シルバー光粒子局外用ゲル

K番号: K192620 · 2020-08-12

決定日2020-08-12

製品コードQCY

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

SNA-001 Silver Photoparticle Topical Gel is the device name listed in this FDA 510(k) record. The listed applicant is Sienna Biopharmaceuticals, Inc.. It received FDA 510(k) clearance on 2020-08-12 under 510(k) number K192620. The device is classified under product code QCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the SNA-001 Silver Photoparticle Topical Gel?

SNA-001 Silver Photoparticle Topical Gel is a medical device that received FDA 510(k) clearance on 2020-08-12. The listed applicant is Sienna Biopharmaceuticals, Inc.. The 510(k) number is K192620.

When did SNA-001 Silver Photoparticle Topical Gel receive FDA 510(k) clearance?

SNA-001 Silver Photoparticle Topical Gel received FDA 510(k) clearance on 2020-08-12, under 510(k) number K192620.

Who is the listed applicant for SNA-001 Silver Photoparticle Topical Gel?

The FDA 510(k) record lists Sienna Biopharmaceuticals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SNA-001 Silver Photoparticle Topical Gel?

The FDA product code for SNA-001 Silver Photoparticle Topical Gel is QCY.

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SNA-001 シルバー光粒子局外用ゲル

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：QCY）

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