COBE SYSTEM 3— 510(k) K851306

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K851306 for COBE SYSTEM 3, Substantially Equivalent on 1985-06-12. 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: 1985-04-01
Decision date: 1985-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

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K905388 — COBE CENTRYSYSTEM 3 BICART OPTION KIT1991-02-11
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Data sourced from openFDA. This site is unofficial and independent of the FDA.