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FDA 510(k)

HYDROXYLINE

K-Number: K833640 · 1984-02-27

Decision Date1984-02-27
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HYDROXYLINE is the device name listed in this FDA 510(k) record. The listed applicant is George Taub Products & Fusion Co., Inc.. It received FDA 510(k) clearance on 1984-02-27 under 510(k) number K833640. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDROXYLINE?

HYDROXYLINE is a medical device that received FDA 510(k) clearance on 1984-02-27. The listed applicant is George Taub Products & Fusion Co., Inc.. The 510(k) number is K833640.

When did HYDROXYLINE receive FDA 510(k) clearance?

HYDROXYLINE received FDA 510(k) clearance on 1984-02-27, under 510(k) number K833640.

Who is the listed applicant for HYDROXYLINE?

The FDA 510(k) record lists George Taub Products & Fusion Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYDROXYLINE?

The FDA product code for HYDROXYLINE is EJK.

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.

Other records listing George Taub Products & Fusion Co., 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.

Related Devices (Code: EJK)

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

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