COBE CENTRY 2 BICART OPTION KIT— 510(k) K905793

Name: FDA 510(k) clearance K905793
Creator: U.S. Food and Drug Administration
Published: 1991-02-12

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K905793 for COBE CENTRY 2 BICART OPTION KIT, Substantially Equivalent on 1991-02-12. 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: 1990-12-27
Decision date: 1991-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

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