BT3/6, BT12— 510(k) K082077

Substantially Equivalent

Corscience GmbH & Co. KG

FDA 510(k) clearance K082077 for BT3/6, BT12, Substantially Equivalent on 2008-09-02. Applicant: Corscience GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Corscience GmbH & Co. KG
Product code: Code DXH
Device class: Class 2
Regulation: 21 CFR 870.2920
Advisory panel: Cardiovascular
Date received: 2008-07-23
Decision date: 2008-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monroeville, PA, 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.