MODIFIED GELMAN ARTERIAL FILTER— 510(k) K892387

Name: FDA 510(k) clearance K892387
Creator: U.S. Food and Drug Administration
Published: 1989-06-22

Substantially Equivalent

Gelman Sciences, Inc.

FDA 510(k) clearance K892387 for MODIFIED GELMAN ARTERIAL FILTER, Substantially Equivalent on 1989-06-22. 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: 1989-04-14
Decision date: 1989-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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