CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE— 510(k) K132896

Name: FDA 510(k) clearance K132896
Creator: U.S. Food and Drug Administration
Published: 2013-12-02

Substantially Equivalent

Asia-Med GmbH and CO KG

FDA 510(k) clearance K132896 for CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE, Substantially Equivalent on 2013-12-02. Applicant: Asia-Med GmbH and CO KG. Device class: 2.

Clearance details

Applicant: Asia-Med GmbH and CO KG
Product code: Code MQX
Device class: Class 2
Regulation: 21 CFR 880.5580
Advisory panel: General Hospital
Date received: 2013-09-16
Decision date: 2013-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, CO, US

Download summary PDF View on FDA.gov ↗

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