TYBR 膠原膠
K 號：K250109 · 2025-06-06
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器材摘要
TYBR Collagen Gel is the device name listed in this FDA 510(k) record. The listed applicant is Tybr Health. It received FDA 510(k) clearance on 2025-06-06 under 510(k) number K250109. The device is classified under product code OWY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the TYBR Collagen Gel?
TYBR Collagen Gel is a medical device that received FDA 510(k) clearance on 2025-06-06. The listed applicant is Tybr Health. The 510(k) number is K250109.
When did TYBR Collagen Gel receive FDA 510(k) clearance?
TYBR Collagen Gel received FDA 510(k) clearance on 2025-06-06, under 510(k) number K250109.
Who is the listed applicant for TYBR Collagen Gel?
The FDA 510(k) record lists Tybr Health as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TYBR Collagen Gel?
The FDA product code for TYBR Collagen Gel is OWY.
相關臨床試驗
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相關器械（代碼：OWY）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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