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FDA 510(k)

AlloX2 Pro组织扩张器

K号: K214124 · 2023-06-08

申请人Sientra, Inc.
决定日期2023-06-08
产品代码LCJ
决定实质等同

器械摘要

AlloX2 Pro Tissue Expanders is the device name listed in this FDA 510(k) record. The listed applicant is Sientra, Inc.. It received FDA 510(k) clearance on 2023-06-08 under 510(k) number K214124. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

常见问题

What is the AlloX2 Pro Tissue Expanders?

AlloX2 Pro Tissue Expanders is a medical device that received FDA 510(k) clearance on 2023-06-08. The listed applicant is Sientra, Inc.. The 510(k) number is K214124.

When did AlloX2 Pro Tissue Expanders receive FDA 510(k) clearance?

AlloX2 Pro Tissue Expanders received FDA 510(k) clearance on 2023-06-08, under 510(k) number K214124.

Who is the listed applicant for AlloX2 Pro Tissue Expanders?

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

What is the FDA product code for AlloX2 Pro Tissue Expanders?

The FDA product code for AlloX2 Pro Tissue Expanders is LCJ.

相关临床试验

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列明Sientra, Inc.为申报人的其他记录

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相关器械(代码:LCJ)

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官方来源

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