PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE— 510(k) K980762

Name: FDA 510(k) clearance K980762
Creator: U.S. Food and Drug Administration
Published: 1998-09-01

Substantially Equivalent

Pall Corp.

FDA 510(k) clearance K980762 for PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE, Substantially Equivalent on 1998-09-01. Applicant: Pall Corp.. Device class: 2.

Clearance details

Applicant: Pall Corp.
Product code: Code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 1998-02-27
Decision date: 1998-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Hills, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.