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FDA 510(k)

PORTSMART NEEDLE DE-ACCESS ENCLOSURE

K-Number: K964559 · 1997-01-03

ApplicantJireh, Inc.
Decision Date1997-01-03
Product CodeLJT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PORTSMART NEEDLE DE-ACCESS ENCLOSURE is the device name listed in this FDA 510(k) record. The listed applicant is Jireh, Inc.. It received FDA 510(k) clearance on 1997-01-03 under 510(k) number K964559. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTSMART NEEDLE DE-ACCESS ENCLOSURE?

PORTSMART NEEDLE DE-ACCESS ENCLOSURE is a medical device that received FDA 510(k) clearance on 1997-01-03. The listed applicant is Jireh, Inc.. The 510(k) number is K964559.

When did PORTSMART NEEDLE DE-ACCESS ENCLOSURE receive FDA 510(k) clearance?

PORTSMART NEEDLE DE-ACCESS ENCLOSURE received FDA 510(k) clearance on 1997-01-03, under 510(k) number K964559.

Who is the listed applicant for PORTSMART NEEDLE DE-ACCESS ENCLOSURE?

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

What is the FDA product code for PORTSMART NEEDLE DE-ACCESS ENCLOSURE?

The FDA product code for PORTSMART NEEDLE DE-ACCESS ENCLOSURE is LJT.

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Related Devices (Code: LJT)

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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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