JZR — Support Gels Class I

FDA Device Classification

FDA product code JZR covers "Support Gels", a Class I medical device regulated under 21 CFR 866.4900. Submissions are reviewed by the Immunology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
JZR
Device Class
Class I
Regulation Number
866.4900
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K940037fmcI.D. AND SEAKEM GTG AGAROSESFebruary 24, 1995
K831603helena laboratoriesTITAN GE/IEPLATEJuly 7, 1983