FDA 510(k)

스타 조직 마커

K-번호: K170905 · 2017-04-27

결정일2017-04-27

제품 코드NEU

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

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기기 요약

Star Tissue Marker is the device name listed in this FDA 510(k) record. The listed applicant is Scion Medical Technologies, LLC. It received FDA 510(k) clearance on 2017-04-27 under 510(k) number K170905. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Star Tissue Marker?

Star Tissue Marker is a medical device that received FDA 510(k) clearance on 2017-04-27. The listed applicant is Scion Medical Technologies, LLC. The 510(k) number is K170905.

When did Star Tissue Marker receive FDA 510(k) clearance?

Star Tissue Marker received FDA 510(k) clearance on 2017-04-27, under 510(k) number K170905.

Who is the listed applicant for Star Tissue Marker?

The FDA 510(k) record lists Scion Medical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Star Tissue Marker?

The FDA product code for Star Tissue Marker is NEU.

Scion Medical Technologies, LLC를 신청인으로 등재한 기타 기록

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