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FDA 510(k)

Stryker ChestShield Sterilization Tray System

K-Number: K183701 · 2019-05-07

ApplicantParagon Medical
Decision Date2019-05-07
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Stryker ChestShield Sterilization Tray System is the device name listed in this FDA 510(k) record. The listed applicant is Paragon Medical. It received FDA 510(k) clearance on 2019-05-07 under 510(k) number K183701. 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 Stryker ChestShield Sterilization Tray System?

Stryker ChestShield Sterilization Tray System is a medical device that received FDA 510(k) clearance on 2019-05-07. The listed applicant is Paragon Medical. The 510(k) number is K183701.

When did Stryker ChestShield Sterilization Tray System receive FDA 510(k) clearance?

Stryker ChestShield Sterilization Tray System received FDA 510(k) clearance on 2019-05-07, under 510(k) number K183701.

Who is the listed applicant for Stryker ChestShield Sterilization Tray System?

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

What is the FDA product code for Stryker ChestShield Sterilization Tray System?

The FDA product code for Stryker ChestShield Sterilization Tray System is KCT.

Other records listing Paragon Medical 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.

K190667Sonopet iQ Sterilization TrayK173615Stryker Universal Select Sterilization Tray System

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.

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.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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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