Stimulator, Electrical For Sperm Collection

Device Code: 2194

Product Code(s): LNL

Device Classification Information

Device Type ID2194
Device NameStimulator, Electrical For Sperm Collection
Review PanelGastroenterology/Urology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Urology And Lithotripsy Devices Branch (ULDB)
Submission Type510(k)
FDA Device ClassificationClass Unclassified Medical Device
Product CodeLNL
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2194
DeviceStimulator, Electrical For Sperm Collection
Product CodeLNL
TPLC Last Update: 2019-04-02 20:07:30

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