FDA 510(k)

PWD 플랫폼 상처 치료 패치 3” x 5” 연장형

K-번호: K191460 · 2019-07-02

결정일2019-07-02

제품 코드OMP

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

결정대체적으로 동일

기기 요약

PWD Platform Wound Dressing 3” x 5” Oblong is the device name listed in this FDA 510(k) record. The listed applicant is Applied Tissue Technologies, LLC. It received FDA 510(k) clearance on 2019-07-02 under 510(k) number K191460. 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 PWD Platform Wound Dressing 3” x 5” Oblong?

PWD Platform Wound Dressing 3” x 5” Oblong is a medical device that received FDA 510(k) clearance on 2019-07-02. The listed applicant is Applied Tissue Technologies, LLC. The 510(k) number is K191460.

When did PWD Platform Wound Dressing 3” x 5” Oblong receive FDA 510(k) clearance?

PWD Platform Wound Dressing 3” x 5” Oblong received FDA 510(k) clearance on 2019-07-02, under 510(k) number K191460.

Who is the listed applicant for PWD Platform Wound Dressing 3” x 5” Oblong?

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

What is the FDA product code for PWD Platform Wound Dressing 3” x 5” Oblong?

The FDA product code for PWD Platform Wound Dressing 3” x 5” Oblong is OMP.

Applied Tissue Technologies, LLC를 신청인으로 등재한 기타 기록

K212359PWD 음압 치료 장비 시스템 K182409Applied Tissue Technologies PWD™ Platform Wound Dressing

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