SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE— 510(k) K031716

Name: FDA 510(k) clearance K031716
Creator: U.S. Food and Drug Administration
Published: 2003-07-10

Substantially Equivalent

Asia-Med GmbH and CO KG

FDA 510(k) clearance K031716 for SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE, Substantially Equivalent on 2003-07-10. 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: 2003-06-03
Decision date: 2003-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, CO, US

Download summary PDF View on FDA.gov ↗

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