HEMOSPAL KITS A1, A2D, AO, & A1D— 510(k) K901368

Name: FDA 510(k) clearance K901368
Creator: U.S. Food and Drug Administration
Published: 1990-08-02

Substantially Equivalent

Gambro-Hospal, Inc.

FDA 510(k) clearance K901368 for HEMOSPAL KITS A1, A2D, AO, & A1D, Substantially Equivalent on 1990-08-02. Applicant: Gambro-Hospal, Inc.. Device class: 2.

Clearance details

Applicant: Gambro-Hospal, Inc.
Product code: Code FJG
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1990-03-23
Decision date: 1990-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Williamsburg, VA, US

Download summary PDF View on FDA.gov ↗

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