HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207— 510(k) K974854

Name: FDA 510(k) clearance K974854
Creator: U.S. Food and Drug Administration
Published: 1998-10-07

Substantially Equivalent

Morax

FDA 510(k) clearance K974854 for HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207, Substantially Equivalent on 1998-10-07. Applicant: Morax. Device class: 1.

Clearance details

Applicant: Morax
Product code: Code JHO
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1997-12-29
Decision date: 1998-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chelsea, MI, US

Download summary PDF View on FDA.gov ↗

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