FDA 510(k) Application Details - K090284

Device Classification Name	Holder, Infant Position   More FDA Info for this Device
510(K) Number	K090284
Device Name	Holder, Infant Position
Applicant	CR ENTERPRISES, LLC. 4701 AUGUSTA DR. FRISCO, TX 75034-6839 US Other 510(k) Applications for this Company
Contact	CRAIG A TROOP Other 510(k) Applications for this Contact
Regulation Number	880.5680   More FDA Info for this Regulation Number
Classification Product Code	FRP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/05/2009
Decision Date	06/05/2009
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