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FDA 510(k)

MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES

K-Number: K101653 · 2010-08-02

ApplicantMiltex, Inc.
Decision Date2010-08-02
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES is the device name listed in this FDA 510(k) record. The listed applicant is Miltex, Inc.. It received FDA 510(k) clearance on 2010-08-02 under 510(k) number K101653. 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 THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES?

MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES is a medical device that received FDA 510(k) clearance on 2010-08-02. The listed applicant is Miltex, Inc.. The 510(k) number is K101653.

When did MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES receive FDA 510(k) clearance?

MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES received FDA 510(k) clearance on 2010-08-02, under 510(k) number K101653.

Who is the listed applicant for MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES?

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 THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES?

The FDA product code for MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES 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.

K092855MILTEX MEMBRANE TACK KITK083796MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHTK072563MILTEX RIGID CONTAINER SYSTEMSK061033MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS)K052018MILTEX 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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