FDA 510(k)

안전한 안정적인 스팀 및 에틸렌 오كس이드 처리 지시표 포장용 비염증 풀

K-번호: K153540 · 2016-08-04

결정일2016-08-04

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

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators is the device name listed in this FDA 510(k) record. The listed applicant is Safe Secure Packaging Co., Ltd.. It received FDA 510(k) clearance on 2016-08-04 under 510(k) number K153540. 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 Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators?

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators is a medical device that received FDA 510(k) clearance on 2016-08-04. The listed applicant is Safe Secure Packaging Co., Ltd.. The 510(k) number is K153540.

When did Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators receive FDA 510(k) clearance?

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators received FDA 510(k) clearance on 2016-08-04, under 510(k) number K153540.

Who is the listed applicant for Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators?

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

What is the FDA product code for Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators?

The FDA product code for Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators is FRG.

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안전한 안정적인 스팀 및 에틸렌 오كس이드 처리 지시표 포장용 비염증 풀

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: FRG)

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