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FDA 510(k)

ProTEC-USA EZDoff 服裝

K 號：K210405 · 2021-12-15

申請人Cadillac Products, Inc.
決定日期2021-12-15
產品代碼QPC
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

ProTEC-USA EZDoff Gown is the device name listed in this FDA 510(k) record. The listed applicant is Cadillac Products, Inc.. It received FDA 510(k) clearance on 2021-12-15 under 510(k) number K210405. The device is classified under product code QPC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ProTEC-USA EZDoff Gown?

ProTEC-USA EZDoff Gown is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Cadillac Products, Inc.. The 510(k) number is K210405.

When did ProTEC-USA EZDoff Gown receive FDA 510(k) clearance?

ProTEC-USA EZDoff Gown received FDA 510(k) clearance on 2021-12-15, under 510(k) number K210405.

Who is the listed applicant for ProTEC-USA EZDoff Gown?

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

What is the FDA product code for ProTEC-USA EZDoff Gown?

The FDA product code for ProTEC-USA EZDoff Gown is QPC.

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官方來源

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