Support Gels

Device Code: 3017

Product Code(s): JZR

Device Classification Information

Device Type ID3017
Device NameSupport Gels
Regulation DescriptionSupport Gel.
Regulation Medical SpecialtyImmunology
Review PanelImmunology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.4900 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJZR
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3017
DeviceSupport Gels
Product CodeJZR
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionSupport Gel.
CFR Regulation Number866.4900 [🔎]
TPLC Last Update: 2019-04-02 20:22:40

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.