Shield, Circumcision

Device Code: 3874

Product Code(s): FHJ

Device Classification Information

Device Type ID3874
Device NameShield, Circumcision
Regulation DescriptionObstetric-gynecologic Specialized Manual Instrument.
Regulation Medical SpecialtyObstetrics/Gynecology
Review PanelObstetrics/Gynecology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Obstetrics And Gynecology Devices Branch (OGDB)
Submission Type510(k)
CFR Regulation Number884.4530 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeFHJ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3874
DeviceShield, Circumcision
Product CodeFHJ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionObstetric-gynecologic Specialized Manual Instrument.
CFR Regulation Number884.4530 [🔎]
TPLC Last Update: 2019-04-02 20:39:13

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