FDA 510(k) Application Details - K150573

Device Classification Name	Intrauterine Tamponade Balloon   More FDA Info for this Device
510(K) Number	K150573
Device Name	Intrauterine Tamponade Balloon
Applicant	CLINICAL INNOVATIONS, LLC 747 WEST 4170 SOUTH MURRAY, UT 84123 US Other 510(k) Applications for this Company
Contact	Tom Haueter Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	OQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/06/2015
Decision Date	03/25/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review