GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON)— 510(k) K862068

Name: FDA 510(k) clearance K862068
Creator: U.S. Food and Drug Administration
Published: 1986-08-08

Substantially Equivalent

Gelman Sciences, Inc.

FDA 510(k) clearance K862068 for GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON), Substantially Equivalent on 1986-08-08. Applicant: Gelman Sciences, Inc.. Device class: 2.

Clearance details

Applicant: Gelman Sciences, Inc.
Product code: Product code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 1986-05-30
Decision date: 1986-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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