COBE REN NEW-D DISPENSING KIT— 510(k) K853817

Name: FDA 510(k) clearance K853817
Creator: U.S. Food and Drug Administration
Published: 1985-10-17

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K853817 for COBE REN NEW-D DISPENSING KIT, Substantially Equivalent on 1985-10-17. Applicant: Cobe Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Cobe Laboratories, Inc.
Product code: Code LIF
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1985-09-12
Decision date: 1985-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

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