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PFJ — Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor Class II

FDA Device Classification

Classification Details

Product Code
PFJ
Device Class
Class II
Regulation Number
884.4260
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Definition

Mechanical dilation of the cervical canal for labor.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K143424utah medical productsUTAH CVX-RIPEAugust 28, 2015
K131206cookCOOK CERVICAL RIPENING BALLOONSeptember 27, 2013