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FDA 510(k)

Peri-Strips乾燥與Veritas膠原蛋白組織與穩固握緊技術（PSDV-SG）

K 號：K192615 · 2019-12-17

申請人Synovis Life Technologies, Inc. (Baxter International Inc.)
決定日期2019-12-17
產品代碼FTM
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

Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) is the device name listed in this FDA 510(k) record. The listed applicant is Synovis Life Technologies, Inc. (Baxter International Inc.). It received FDA 510(k) clearance on 2019-12-17 under 510(k) number K192615. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)?

Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) is a medical device that received FDA 510(k) clearance on 2019-12-17. The listed applicant is Synovis Life Technologies, Inc. (Baxter International Inc.). The 510(k) number is K192615.

When did Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) receive FDA 510(k) clearance?

Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) received FDA 510(k) clearance on 2019-12-17, under 510(k) number K192615.

Who is the listed applicant for Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)?

The FDA 510(k) record lists Synovis Life Technologies, Inc. (Baxter International Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)?

The FDA product code for Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) is FTM.

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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。

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官方來源

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