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FDA 510(k)

SNA-001 銀光子膠體外用凝胶

K 號:K192620 · 2020-08-12

決定日期2020-08-12
產品代碼QCY
諮詢委員會SU 請提供完整的描述文本,以便我進行翻譯。
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

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相關器械(代碼:QCY)

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

官方來源

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