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510(k) K032445

Device
THE ULTRA SYSTEM
Applicant
PROMEDICA, INC.
510(k) number
K032445
Product code
KCT  
Decision
Substantially Equivalent (SESE)
Decision date
2004-03-29
Date received
2003-08-08
Regulation
880.6850
Classification name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RICHARD BLOOM
Address
114 Douglas Rd. E. Oldsmar FL US 34677 34677

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KCT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.2026-02-26
K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.2026-02-06
K251756Sterilization TraysParagon Implant Mfg., LLC2025-11-14
K251300Plastic Surgical KitsDentsply Sirona, Inc.2025-07-22
K243425Guided DAS Surgical KitTalladium España, SL2025-07-22
K243589PAL Sterilization CaseMicroaire Surgical Instruments, LLC2025-06-20
K242762Aesculap Aicon® Series Container SystemAesculap, Inc.2025-05-13
K250029ONE TRAY® Sealed Sterilization Container SystemInnovative Sterilization Technologies2025-05-01
K241927Synthes Graphic Case & Tray SystemSynthes GmbH2025-03-28
K242564Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)Prismatik Dentalcraft, Inc.2025-03-21
K242023Microdent Sterilization CassetteImplant Microdent System S.L.U.2025-02-19
K243317NUVENTUS NV.C™ Surgical Cassette and TrayInfinitum Eta, Ltd.2025-02-11
K242834System 9 Sterile Battery ContainerStryker Instruments2025-01-16
K243128Klockner KitsSOADCO, S.L.2024-12-18
K241492Guided Surgery Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.2024-08-23

Legacy Summary#

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FDA Review#

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