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FDA 510(k)

PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS

K-Number: K032119 · 2003-10-29

ApplicantParagon Medical, Inc.
Decision Date2003-10-29
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS is the device name listed in this FDA 510(k) record. The listed applicant is Paragon Medical, Inc.. It received FDA 510(k) clearance on 2003-10-29 under 510(k) number K032119. 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 PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS?

PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS is a medical device that received FDA 510(k) clearance on 2003-10-29. The listed applicant is Paragon Medical, Inc.. The 510(k) number is K032119.

When did PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS receive FDA 510(k) clearance?

PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS received FDA 510(k) clearance on 2003-10-29, under 510(k) number K032119.

Who is the listed applicant for PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS?

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

What is the FDA product code for PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS?

The FDA product code for PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS is KCT.

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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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