HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134— 510(k) K022053

Name: FDA 510(k) clearance K022053
Creator: U.S. Food and Drug Administration
Published: 2002-07-12

Substantially Equivalent

Sebia

FDA 510(k) clearance K022053 for HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134, Substantially Equivalent on 2002-07-12. Applicant: Sebia. Device class: 1.

Clearance details

Applicant: Sebia
Product code: Code JHO
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 2002-06-24
Decision date: 2002-07-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Chelsea, MI, US

Download summary PDF View on FDA.gov ↗

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