MEDICOM SELF-SEALING STERILIZATION POUCH— 510(k) K070428

Name: FDA 510(k) clearance K070428
Creator: U.S. Food and Drug Administration
Published: 2007-07-17

Substantially Equivalent

A.R. Medicom, Inc.

FDA 510(k) clearance K070428 for MEDICOM SELF-SEALING STERILIZATION POUCH, Substantially Equivalent on 2007-07-17. Applicant: A.R. Medicom, Inc.. Device class: 2.

Clearance details

Applicant: A.R. Medicom, Inc.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2007-02-13
Decision date: 2007-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lachine (Montreal), CA

Download summary PDF View on FDA.gov ↗

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