STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05— 510(k) K103469

Name: FDA 510(k) clearance K103469
Creator: U.S. Food and Drug Administration
Published: 2011-01-18

Substantially Equivalent

Sorin Group Deutschland GmbH

FDA 510(k) clearance K103469 for STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05, Substantially Equivalent on 2011-01-18. Applicant: Sorin Group Deutschland GmbH. Device class: 2.

Clearance details

Applicant: Sorin Group Deutschland GmbH
Product code: Code KRL
Device class: Class 2
Regulation: 21 CFR 870.4205
Advisory panel: Cardiovascular
Date received: 2010-11-24
Decision date: 2011-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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