K3PRO SURGICAL TRAY— 510(k) K160574

Name: FDA 510(k) clearance K160574
Creator: U.S. Food and Drug Administration
Published: 2016-12-20

Substantially Equivalent

Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG

FDA 510(k) clearance K160574 for K3PRO SURGICAL TRAY, Substantially Equivalent on 2016-12-20. Applicant: Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG. Device class: 2.

Clearance details

Applicant: Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2016-03-01
Decision date: 2016-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bingen Am Rhein, DE

Download summary PDF View on FDA.gov ↗

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