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FDA 510(k)

THE ULTRA SYSTEM

K-Number: K032445 · 2004-03-29

ApplicantPromedica, Inc.
Decision Date2004-03-29
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THE ULTRA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Promedica, Inc.. It received FDA 510(k) clearance on 2004-03-29 under 510(k) number K032445. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE ULTRA SYSTEM?

THE ULTRA SYSTEM is a medical device that received FDA 510(k) clearance on 2004-03-29. The listed applicant is Promedica, Inc.. The 510(k) number is K032445.

When did THE ULTRA SYSTEM receive FDA 510(k) clearance?

THE ULTRA SYSTEM received FDA 510(k) clearance on 2004-03-29, under 510(k) number K032445.

Who is the listed applicant for THE ULTRA SYSTEM?

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

What is the FDA product code for THE ULTRA SYSTEM?

The FDA product code for THE ULTRA SYSTEM is KCT.

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.

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Other records listing Promedica, 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.

K032813THE ULTRA SYSTEM SP

Related Devices (Code: KCT)

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.

K253988LiteSet TraysNobel Biocare ABK261935Surgical and Prosthetic TraysDentsply Sirona, Inc.K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.

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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