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FDA 510(k)

Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)

K-Number: K200557 · 2020-09-28

Decision Date2020-09-28
Product CodePNR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Shenli Medical Production Co., Ltd.. It received FDA 510(k) clearance on 2020-09-28 under 510(k) number K200557. The device is classified under product code PNR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)?

Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) is a medical device that received FDA 510(k) clearance on 2020-09-28. The listed applicant is Jiangsu Shenli Medical Production Co., Ltd.. The 510(k) number is K200557.

When did Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) receive FDA 510(k) clearance?

Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) received FDA 510(k) clearance on 2020-09-28, under 510(k) number K200557.

Who is the listed applicant for Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)?

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

What is the FDA product code for Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)?

The FDA product code for Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) is PNR.

Other records listing Jiangsu Shenli Medical Production Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: PNR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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