HYDRAGEL CSF ISOFOCUSING KITS— 510(k) K033277

Clearance details

Applicant

Morax

Product code

Code CFF

Device class

Class 2

Regulation

21 CFR 866.5510

Advisory panel

Immunology

Date received

2003-10-10

Decision date

2003-11-04

Decision

Substantially Equivalent

Clearance type

Special

Location

Norcross, GA, US

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