Support, Hernia

Device Code: 1683

Product Code(s): EXN

Device Classification Information

Device Type ID1683
Device NameSupport, Hernia
Regulation DescriptionHernia Support.
Regulation Medical SpecialtyGastroenterology/Urology
Review PanelGastroenterology/Urology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Gastroenterology Devices Branch (GEDB)
Submission Type510(K) Exempt
CFR Regulation Number876.5970 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeEXN
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1683
DeviceSupport, Hernia
Product CodeEXN
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionHernia Support.
CFR Regulation Number876.5970 [🔎]
TPLC Last Update: 2019-04-02 19:57:44

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