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FDA 510(k)

AUTOPAK INSTRUMENT TRAY STERILIZATION POUCH

K-Number: K932086 · 1994-11-17

ApplicantOngard Meddevice Packaging, Inc.
Decision Date1994-11-17
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AUTOPAK INSTRUMENT TRAY STERILIZATION POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Ongard Meddevice Packaging, Inc.. It received FDA 510(k) clearance on 1994-11-17 under 510(k) number K932086. 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 AUTOPAK INSTRUMENT TRAY STERILIZATION POUCH?

AUTOPAK INSTRUMENT TRAY STERILIZATION POUCH is a medical device that received FDA 510(k) clearance on 1994-11-17. The listed applicant is Ongard Meddevice Packaging, Inc.. The 510(k) number is K932086.

When did AUTOPAK INSTRUMENT TRAY STERILIZATION POUCH receive FDA 510(k) clearance?

AUTOPAK INSTRUMENT TRAY STERILIZATION POUCH received FDA 510(k) clearance on 1994-11-17, under 510(k) number K932086.

Who is the listed applicant for AUTOPAK INSTRUMENT TRAY STERILIZATION POUCH?

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

What is the FDA product code for AUTOPAK INSTRUMENT TRAY STERILIZATION POUCH?

The FDA product code for AUTOPAK INSTRUMENT TRAY STERILIZATION POUCH is KCT.

Related Clinical Trials

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Other records listing Ongard Meddevice Packaging, 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.

K932088AUTOPAK STERILIZATION POUCH

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

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

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