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FDA 510(k)

FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD

K-Number: K072479 · 2007-11-09

ApplicantRapid Injection Systems Corp.
Decision Date2007-11-09
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Injection Systems Corp.. It received FDA 510(k) clearance on 2007-11-09 under 510(k) number K072479. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD?

FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD is a medical device that received FDA 510(k) clearance on 2007-11-09. The listed applicant is Rapid Injection Systems Corp.. The 510(k) number is K072479.

When did FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD receive FDA 510(k) clearance?

FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD received FDA 510(k) clearance on 2007-11-09, under 510(k) number K072479.

Who is the listed applicant for FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD?

The FDA 510(k) record lists Rapid Injection Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD?

The FDA product code for FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD is EBI.

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Other records listing Rapid Injection Systems Corp. 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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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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