Pap Smear Kit

Device Code: 4060

Product Code(s): OHL

Definition: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.Fda.Gov/cdrh/ode/convkit.Html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is

Device Classification Information

Device Type ID4060
Device NamePap Smear Kit
Physical StateThis Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is
Technical MethodThis Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is
Target AreaThis Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is
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 TypeEnforcement Discretion
CFR Regulation Number884.4530 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeOHL
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4060
DevicePap Smear Kit
Product CodeOHL
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionObstetric-gynecologic Specialized Manual Instrument.
CFR Regulation Number884.4530 [🔎]
TPLC Last Update: 2019-04-02 20:42:22

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