FDA 510(k)

Tamper Evident Cap For use with ENFit Syringes

K-번호: K170672 · 2017-10-06

신청자International Medical Industries, Inc.

결정일2017-10-06

제품 코드PNR

자문 위원회GU

결정Substantially Equivalent

기기 요약

Tamper Evident Cap For use with ENFit Syringes is the device name listed in this FDA 510(k) record. The listed applicant is International Medical Industries, Inc.. It received FDA 510(k) clearance on 2017-10-06 under 510(k) number K170672. The device is classified under product code PNR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Tamper Evident Cap For use with ENFit Syringes?

Tamper Evident Cap For use with ENFit Syringes is a medical device that received FDA 510(k) clearance on 2017-10-06. The listed applicant is International Medical Industries, Inc.. The 510(k) number is K170672.

When did Tamper Evident Cap For use with ENFit Syringes receive FDA 510(k) clearance?

Tamper Evident Cap For use with ENFit Syringes received FDA 510(k) clearance on 2017-10-06, under 510(k) number K170672.

Who is the listed applicant for Tamper Evident Cap For use with ENFit Syringes?

The FDA 510(k) record lists International Medical Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tamper Evident Cap For use with ENFit Syringes?

The FDA product code for Tamper Evident Cap For use with ENFit Syringes is PNR.

International Medical Industries, Inc.를 신청인으로 등재한 기타 기록

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