FDA 510(k) Application Details - K062261

Device Classification Name	Port, Protector/Cushion   More FDA Info for this Device
510(K) Number	K062261
Device Name	Port, Protector/Cushion
Applicant	INSPIRED IDEAS, INCORPORATED 11460 N. MERIDIAN STREET SUITE 150 CARMEL, IN 46032 US Other 510(k) Applications for this Company
Contact	Allison Scott Other 510(k) Applications for this Contact
Regulation Number	880.5965   More FDA Info for this Regulation Number
Classification Product Code	OBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/2006
Decision Date	04/09/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review