Drain, Cervical

Device Code: 3933

Product Code(s): HFL

Device Classification Information

Device Type ID3933
Device NameDrain, Cervical
Regulation DescriptionCervical Drain.
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) Exempt
CFR Regulation Number884.3200 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHFL
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID3933
DeviceDrain, Cervical
Product CodeHFL
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionCervical Drain.
CFR Regulation Number884.3200 [🔎]
TPLC Last Update: 2019-04-02 20:40:17

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