FDA 510(k)

Prevena Restor Adapti-Form Dressing

K-번호: K220660 · 2022-07-01

결정일2022-07-01

제품 코드OMP

자문 위원회SU

결정Substantially Equivalent

기기 요약

Prevena Restor Adapti-Form Dressing is the device name listed in this FDA 510(k) record. The listed applicant is 3M Healthcare Business Group. It received FDA 510(k) clearance on 2022-07-01 under 510(k) number K220660. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Prevena Restor Adapti-Form Dressing?

Prevena Restor Adapti-Form Dressing is a medical device that received FDA 510(k) clearance on 2022-07-01. The listed applicant is 3M Healthcare Business Group. The 510(k) number is K220660.

When did Prevena Restor Adapti-Form Dressing receive FDA 510(k) clearance?

Prevena Restor Adapti-Form Dressing received FDA 510(k) clearance on 2022-07-01, under 510(k) number K220660.

Who is the listed applicant for Prevena Restor Adapti-Form Dressing?

The FDA 510(k) record lists 3M Healthcare Business Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prevena Restor Adapti-Form Dressing?

The FDA product code for Prevena Restor Adapti-Form Dressing is OMP.

3M Healthcare Business Group를 신청인으로 등재한 기타 기록

K2215853M V.A.C. 베라플로 클리너 체이스 드레싱 키트, 3M V.A.C. 베라플로 클리너 체이스 컴플리트 드레싱 키트 K210135PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing K2115213M 베라플로 클리너 체이스 컴플리트 드레싱 키트 (중형 드레싱 키트: VFCCC05MD, 대형 드레싱 키트: VFCCC05LG)K212320Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac

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