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FDA 510(k)

U Deliver Bolink ENFit Enteral Feeding Sets

K-Number: K190310 · 2019-05-31

ApplicantU Deliver Medical, LLC
Decision Date2019-05-31
Product CodePIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

U Deliver Bolink ENFit Enteral Feeding Sets is the device name listed in this FDA 510(k) record. The listed applicant is U Deliver Medical, LLC. It received FDA 510(k) clearance on 2019-05-31 under 510(k) number K190310. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the U Deliver Bolink ENFit Enteral Feeding Sets?

U Deliver Bolink ENFit Enteral Feeding Sets is a medical device that received FDA 510(k) clearance on 2019-05-31. The listed applicant is U Deliver Medical, LLC. The 510(k) number is K190310.

When did U Deliver Bolink ENFit Enteral Feeding Sets receive FDA 510(k) clearance?

U Deliver Bolink ENFit Enteral Feeding Sets received FDA 510(k) clearance on 2019-05-31, under 510(k) number K190310.

Who is the listed applicant for U Deliver Bolink ENFit Enteral Feeding Sets?

The FDA 510(k) record lists U Deliver Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U Deliver Bolink ENFit Enteral Feeding Sets?

The FDA product code for U Deliver Bolink ENFit Enteral Feeding Sets is PIF.

Other records listing U Deliver Medical, LLC 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.

K170555U Deliver Bolink ENFit Enteral Feeding Sets

Related Devices (Code: PIF)

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.

K254170Percutaneous Endoscopic Gastrostomy (PEG) KitDegania Silicone , Ltd.K242917Enteral Drainage System, Enteral Medicine strawHMC Premedical S.p.A.K250481Extension Feeding Set with ENFit™ ConnectorsSKY Medical, a.s.K240052Disposable Enteral Feeding SetsBeijing L&Z Medical Technology Development Co., Ltd.K233034Mobility+ Enteral Feeding System OTCRockfield MedicalK230326ENFit to ENFit Extension SetsVesco Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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