COBE ACUFLEX SSN, #15-220— 510(k) K820238

Name: FDA 510(k) clearance K820238
Creator: U.S. Food and Drug Administration
Published: 1982-03-10

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K820238 for COBE ACUFLEX SSN, #15-220, Substantially Equivalent on 1982-03-10. Applicant: Cobe Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Cobe Laboratories, Inc.
Product code: Code LFJ
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 1982-01-28
Decision date: 1982-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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