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FDA 510(k)

ENTERAL BAG/SET

K-Number: K890151 · 1989-05-23

ApplicantAshley Health Care, Inc.
Decision Date1989-05-23
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENTERAL BAG/SET is the device name listed in this FDA 510(k) record. The listed applicant is Ashley Health Care, Inc.. It received FDA 510(k) clearance on 1989-05-23 under 510(k) number K890151. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTERAL BAG/SET?

ENTERAL BAG/SET is a medical device that received FDA 510(k) clearance on 1989-05-23. The listed applicant is Ashley Health Care, Inc.. The 510(k) number is K890151.

When did ENTERAL BAG/SET receive FDA 510(k) clearance?

ENTERAL BAG/SET received FDA 510(k) clearance on 1989-05-23, under 510(k) number K890151.

Who is the listed applicant for ENTERAL BAG/SET?

The FDA 510(k) record lists Ashley Health Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENTERAL BAG/SET?

The FDA product code for ENTERAL BAG/SET is KNT.

Related Clinical Trials

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.

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Other records listing Ashley Health Care, Inc. 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.

K890679SCALP VEIN SET

Related Devices (Code: KNT)

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.

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Official Source

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

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