FDA 510(k)

스테리라이제이션 포치/롤 (Tyvek로 제작)

K-번호: K180672 · 2018-06-06

결정일2018-06-06

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

Sterilization Pouch/Roll Made with Tyvek is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Medical Supplies Corporation. It received FDA 510(k) clearance on 2018-06-06 under 510(k) number K180672. 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 Sterilization Pouch/Roll Made with Tyvek?

Sterilization Pouch/Roll Made with Tyvek is a medical device that received FDA 510(k) clearance on 2018-06-06. The listed applicant is Sigma Medical Supplies Corporation. The 510(k) number is K180672.

When did Sterilization Pouch/Roll Made with Tyvek receive FDA 510(k) clearance?

Sterilization Pouch/Roll Made with Tyvek received FDA 510(k) clearance on 2018-06-06, under 510(k) number K180672.

Who is the listed applicant for Sterilization Pouch/Roll Made with Tyvek?

The FDA 510(k) record lists Sigma Medical Supplies Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterilization Pouch/Roll Made with Tyvek?

The FDA product code for Sterilization Pouch/Roll Made with Tyvek is FRG.

Sigma Medical Supplies Corporation를 신청인으로 등재한 기타 기록

K202462SIGMA 소독 포치 및 롤

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