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510(k) K954185

Device
RE-BAG MULTI-USE POUCH, LARGE & SMALL
Applicant
MILTEX, INC.
510(k) number
K954185
Product code
KCT  
Decision
Substantially Equivalent - Kit (SESK)
Decision date
1995-12-04
Date received
1995-09-06
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
CAROLANN KOTULA
Address
55 Northern Blvd. Great Neck NY US 11021 11021

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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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