FDA 510(k)

AquaFlate 预充无菌水注射器 10mL

K号: K200556 · 2020-03-31

决定日期2020-03-31

产品代码EZL

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决定实质等同

器械摘要

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.

常见问题

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.

列明H R Pharmaceuticals, Inc.为申报人的其他记录

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