FDA 510(k) Application Details - K130644

Device Classification Name	Stroller, Adaptive   More FDA Info for this Device
510(K) Number	K130644
Device Name	Stroller, Adaptive
Applicant	COLUMBIA MEDICAL MFG, LLC 11724 WILLAKE ST SANTA FE SPRINGS, CA 90670 US Other 510(k) Applications for this Company
Contact	GARY WERSCHMIDT Other 510(k) Applications for this Contact
Regulation Number	890.3850   More FDA Info for this Regulation Number
Classification Product Code	LBE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/11/2013
Decision Date	10/16/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review