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FDA 510(k)

SEDECAL, MILLENNIUM PLUS

K-Number: K090279 · 2009-03-11

ApplicantSedecal., Sa.
Decision Date2009-03-11
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SEDECAL, MILLENNIUM PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Sedecal., Sa.. It received FDA 510(k) clearance on 2009-03-11 under 510(k) number K090279. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEDECAL, MILLENNIUM PLUS?

SEDECAL, MILLENNIUM PLUS is a medical device that received FDA 510(k) clearance on 2009-03-11. The listed applicant is Sedecal., Sa.. The 510(k) number is K090279.

When did SEDECAL, MILLENNIUM PLUS receive FDA 510(k) clearance?

SEDECAL, MILLENNIUM PLUS received FDA 510(k) clearance on 2009-03-11, under 510(k) number K090279.

Who is the listed applicant for SEDECAL, MILLENNIUM PLUS?

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

What is the FDA product code for SEDECAL, MILLENNIUM PLUS?

The FDA product code for SEDECAL, MILLENNIUM PLUS is KPR.

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 Sedecal., Sa. 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: KPR)

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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