FDA 510(k)

가용한 의료 장비 자동 막힘 스타일리제이션 포치, 일회용 의료 장비 스타일리제이션 루프 포치

K-번호: K193561 · 2020-04-15

신청자Weihai Xingtai Packaging Products Co., Ltd.

결정일2020-04-15

제품 코드FRG

자문 위원회의료장비 규제 텍스트 번역 HO [원문 텍스트가 제공되지 않았기 때문에 번역할 수 없습니다. 원문 텍스트를 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch is the device name listed in this FDA 510(k) record. The listed applicant is Weihai Xingtai Packaging Products Co., Ltd.. It received FDA 510(k) clearance on 2020-04-15 under 510(k) number K193561. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch?

Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch is a medical device that received FDA 510(k) clearance on 2020-04-15. The listed applicant is Weihai Xingtai Packaging Products Co., Ltd.. The 510(k) number is K193561.

When did Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch receive FDA 510(k) clearance?

Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch received FDA 510(k) clearance on 2020-04-15, under 510(k) number K193561.

Who is the listed applicant for Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch?

The FDA 510(k) record lists Weihai Xingtai Packaging Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch?

The FDA product code for Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch is FRG.

Weihai Xingtai Packaging Products Co., Ltd.를 신청인으로 등재한 기타 기록

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