AUTOPAK STERILIZATION POUCH— 510(k) K932088

Name: FDA 510(k) clearance K932088
Creator: U.S. Food and Drug Administration
Published: 1994-11-17

Substantially Equivalent

Ongard Meddevice Packaging, Inc.

FDA 510(k) clearance K932088 for AUTOPAK STERILIZATION POUCH, Substantially Equivalent on 1994-11-17. Applicant: Ongard Meddevice Packaging, Inc.. Device class: 2.

Clearance details

Applicant: Ongard Meddevice Packaging, Inc.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 1993-04-30
Decision date: 1994-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.