FDA 510(k)

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K-번호: K171956 · 2017-12-12

신청자Changzhou Detain Medical Devices Co., Ltd.

결정일2017-12-12

제품 코드FCG

자문 위원회규제 정책: medical-regulatory-v1 GU

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기기 요약

Sterile Endoscope Biopsy Sampling Needle is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Detain Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2017-12-12 under 510(k) number K171956. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Sterile Endoscope Biopsy Sampling Needle?

Sterile Endoscope Biopsy Sampling Needle is a medical device that received FDA 510(k) clearance on 2017-12-12. The listed applicant is Changzhou Detain Medical Devices Co., Ltd.. The 510(k) number is K171956.

When did Sterile Endoscope Biopsy Sampling Needle receive FDA 510(k) clearance?

Sterile Endoscope Biopsy Sampling Needle received FDA 510(k) clearance on 2017-12-12, under 510(k) number K171956.

Who is the listed applicant for Sterile Endoscope Biopsy Sampling Needle?

The FDA 510(k) record lists Changzhou Detain Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Endoscope Biopsy Sampling Needle?

The FDA product code for Sterile Endoscope Biopsy Sampling Needle is FCG.

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관련 임상시험

관련 기기 (코드: FCG)

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