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510(k) K143424

UTAH CVX-RIPE by Utah Medical Products, Inc. — Product Code PFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2015
Date Received
December 1, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
Device Class
Class II
Regulation Number
884.4260
Review Panel
OB
Submission Type

Mechanical dilation of the cervical canal for labor.

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  • K955663 — ABC IN-LINE BLOOD SAMPLING KIT (March 17, 1997)
  • K964526 — LIBERTY RECTAL PELVIC FLOOR EXERCISER (February 10, 1997)
  • K961424 — INTRAN 500 (July 10, 1996)

Other clearances for product code PFJ

  • K131206 — COOK CERVICAL RIPENING BALLOON (September 27, 2013)