HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1— 510(k) K990229

Name: FDA 510(k) clearance K990229
Creator: U.S. Food and Drug Administration
Published: 1999-11-04

Substantially Equivalent

Justec Medical Products, Inc.

FDA 510(k) clearance K990229 for HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1, Substantially Equivalent on 1999-11-04. Applicant: Justec Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Justec Medical Products, Inc.
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 1999-01-25
Decision date: 1999-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Holbrook, NY, US

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