FDA 510(k)

수지메드 MP 콜라겐 매트릭스,軟조 재건용

K-번호: K162965 · 2017-02-16

결정일2017-02-16

제품 코드FTM

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

결정대체적으로 동일

기기 요약

SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction is the device name listed in this FDA 510(k) record. The listed applicant is Tei Biosciences, Inc.. It received FDA 510(k) clearance on 2017-02-16 under 510(k) number K162965. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction?

SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction is a medical device that received FDA 510(k) clearance on 2017-02-16. The listed applicant is Tei Biosciences, Inc.. The 510(k) number is K162965.

When did SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction receive FDA 510(k) clearance?

SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction received FDA 510(k) clearance on 2017-02-16, under 510(k) number K162965.

Who is the listed applicant for SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction?

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

What is the FDA product code for SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction?

The FDA product code for SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction is FTM.

Tei Biosciences, Inc.를 신청인으로 등재한 기타 기록

K153690PriMatrix 피부 재건 지지대

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