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FDA 510(k)

MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS)

K-Number: K061033 · 2006-12-12

ApplicantMiltex, Inc.
Decision Date2006-12-12
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS) is the device name listed in this FDA 510(k) record. The listed applicant is Miltex, Inc.. It received FDA 510(k) clearance on 2006-12-12 under 510(k) number K061033. 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 MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS)?

MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS) is a medical device that received FDA 510(k) clearance on 2006-12-12. The listed applicant is Miltex, Inc.. The 510(k) number is K061033.

When did MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS) receive FDA 510(k) clearance?

MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS) received FDA 510(k) clearance on 2006-12-12, under 510(k) number K061033.

Who is the listed applicant for MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS)?

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

What is the FDA product code for MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS)?

The FDA product code for MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS) is KCT.

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Other records listing Miltex, 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.

K101653MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTESK092855MILTEX MEMBRANE TACK KITK083796MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHTK072563MILTEX RIGID CONTAINER SYSTEMSK052018MILTEX LIGATING CLIPK050570MILTEX RIGID STERILIZATION CONTAINER SYSTEM

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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