COBE CENTRYSYSTEM 3 BICART OPTION KIT— 510(k) K905388

Name: FDA 510(k) clearance K905388
Creator: U.S. Food and Drug Administration
Published: 1991-02-11

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K905388 for COBE CENTRYSYSTEM 3 BICART OPTION KIT, Substantially Equivalent on 1991-02-11. Applicant: Cobe Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Cobe Laboratories, Inc.
Product code: Code FKP
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1990-11-30
Decision date: 1991-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

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