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FDA 510(k)

LUMILOC (TM) SAFETY INTRODUCER NEEDLE

K-Number: K070449 · 2007-06-14

ApplicantSpecialized Health Products International, Inc.
Decision Date2007-06-14
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LUMILOC (TM) SAFETY INTRODUCER NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Specialized Health Products International, Inc.. It received FDA 510(k) clearance on 2007-06-14 under 510(k) number K070449. 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 LUMILOC (TM) SAFETY INTRODUCER NEEDLE?

LUMILOC (TM) SAFETY INTRODUCER NEEDLE is a medical device that received FDA 510(k) clearance on 2007-06-14. The listed applicant is Specialized Health Products International, Inc.. The 510(k) number is K070449.

When did LUMILOC (TM) SAFETY INTRODUCER NEEDLE receive FDA 510(k) clearance?

LUMILOC (TM) SAFETY INTRODUCER NEEDLE received FDA 510(k) clearance on 2007-06-14, under 510(k) number K070449.

Who is the listed applicant for LUMILOC (TM) SAFETY INTRODUCER NEEDLE?

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

What is the FDA product code for LUMILOC (TM) SAFETY INTRODUCER NEEDLE?

The FDA product code for LUMILOC (TM) SAFETY INTRODUCER NEEDLE is KNT.

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Other records listing Specialized Health Products International, 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.

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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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