ZP4皮肤闭合装置
K号: K170003 · 2017-08-18
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决定日期2017-08-18
产品代码PYO
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
Zip 4 Skin Closure Device is the device name listed in this FDA 510(k) record. The listed applicant is Zipline Medical, Inc.. It received FDA 510(k) clearance on 2017-08-18 under 510(k) number K170003. The device is classified under product code PYO. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Zip 4 Skin Closure Device?
Zip 4 Skin Closure Device is a medical device that received FDA 510(k) clearance on 2017-08-18. The listed applicant is Zipline Medical, Inc.. The 510(k) number is K170003.
When did Zip 4 Skin Closure Device receive FDA 510(k) clearance?
Zip 4 Skin Closure Device received FDA 510(k) clearance on 2017-08-18, under 510(k) number K170003.
Who is the listed applicant for Zip 4 Skin Closure Device?
The FDA 510(k) record lists Zipline Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Zip 4 Skin Closure Device?
The FDA product code for Zip 4 Skin Closure Device is PYO.
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官方来源
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