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U.S. Department of Health and Human Services

Product Classification

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Device catheter, balloon, dilation of cervical canal
Regulation Description Hygroscopic Laminaria cervical dilator.
Definition Mechanical dilation of the cervical canal for labor.
Physical State Catheter with inflatable balloon
Technical Method Use mechanical force to dilate cervix to prepare for vaginal delivery.
Target Area Uterine cervix
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodePFJ
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Obstetrics and Gynecology Devices Branch (OGDB)
Submission Type 510(k)
Regulation Number 884.4260
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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