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U.S. Department of Health and Human Services

Product Classification

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Device electrode, clip, fetal scalp (and applicator)
Regulation Description Fetal scalp clip electrode and applicator.
Definition Call for pmas to be filed by 12/26/96 per 61 fr 50708 on 9/27/96.
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodeHIQ
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Obstetrics and Gynecology Devices Branch (OGDB)
Submission Type PMA
Regulation Number 884.2685
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible