FDA 510(k)

I.V. EXTENSION SET OR I.V. ADMINISTRATION SET

K-Number: K983073 · 1998-12-16

Decision Date1998-12-16

Product CodeFPA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

I.V. EXTENSION SET OR I.V. ADMINISTRATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Integra Biotechnical, LLC. It received FDA 510(k) clearance on 1998-12-16 under 510(k) number K983073. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I.V. EXTENSION SET OR I.V. ADMINISTRATION SET?

I.V. EXTENSION SET OR I.V. ADMINISTRATION SET is a medical device that received FDA 510(k) clearance on 1998-12-16. The listed applicant is Integra Biotechnical, LLC. The 510(k) number is K983073.

When did I.V. EXTENSION SET OR I.V. ADMINISTRATION SET receive FDA 510(k) clearance?

I.V. EXTENSION SET OR I.V. ADMINISTRATION SET received FDA 510(k) clearance on 1998-12-16, under 510(k) number K983073.

Who is the listed applicant for I.V. EXTENSION SET OR I.V. ADMINISTRATION SET?

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

What is the FDA product code for I.V. EXTENSION SET OR I.V. ADMINISTRATION SET?

The FDA product code for I.V. EXTENSION SET OR I.V. ADMINISTRATION SET is FPA.

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Related Devices (Code: FPA)

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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.