FDA 510(k)

AquaFlate преднаполненная стерильная шприц-ручка с водой 10 мл

K-번호: K200556 · 2020-03-31

결정일2020-03-31

제품 코드EZL

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

AquaFlate Pre-Filled Sterile Water Syringe 10mL is the device name listed in this FDA 510(k) record. The listed applicant is H R Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2020-03-31 under 510(k) number K200556. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the AquaFlate Pre-Filled Sterile Water Syringe 10mL?

AquaFlate Pre-Filled Sterile Water Syringe 10mL is a medical device that received FDA 510(k) clearance on 2020-03-31. The listed applicant is H R Pharmaceuticals, Inc.. The 510(k) number is K200556.

When did AquaFlate Pre-Filled Sterile Water Syringe 10mL receive FDA 510(k) clearance?

AquaFlate Pre-Filled Sterile Water Syringe 10mL received FDA 510(k) clearance on 2020-03-31, under 510(k) number K200556.

Who is the listed applicant for AquaFlate Pre-Filled Sterile Water Syringe 10mL?

The FDA 510(k) record lists H R Pharmaceuticals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AquaFlate Pre-Filled Sterile Water Syringe 10mL?

The FDA product code for AquaFlate Pre-Filled Sterile Water Syringe 10mL is EZL.

H R Pharmaceuticals, Inc.를 신청인으로 등재한 기타 기록

K181363에코뷰 스타일리드 및 비스타일리드 울트라사운드 젤

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