FDA 510(k)

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K-번호: K202517 · 2021-07-09

결정일2021-07-09

제품 코드QAI

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

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기기 요약

Cytrellis Dermal Micro-Coring System is the device name listed in this FDA 510(k) record. The listed applicant is Cytrellis Biosystems, Inc.. It received FDA 510(k) clearance on 2021-07-09 under 510(k) number K202517. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Cytrellis Dermal Micro-Coring System?

Cytrellis Dermal Micro-Coring System is a medical device that received FDA 510(k) clearance on 2021-07-09. The listed applicant is Cytrellis Biosystems, Inc.. The 510(k) number is K202517.

When did Cytrellis Dermal Micro-Coring System receive FDA 510(k) clearance?

Cytrellis Dermal Micro-Coring System received FDA 510(k) clearance on 2021-07-09, under 510(k) number K202517.

Who is the listed applicant for Cytrellis Dermal Micro-Coring System?

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

What is the FDA product code for Cytrellis Dermal Micro-Coring System?

The FDA product code for Cytrellis Dermal Micro-Coring System is QAI.

Cytrellis Biosystems, Inc.를 신청인으로 등재한 기타 기록

K252752ellacor System with Micro-Coring Technology

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