FDA 510(k) Application Details - K123411

Device Classification Name	More FDA Info for this Device
510(K) Number	K123411
Device Name	LITTLE ANGELS SWADDLING BLANKET
Applicant	BIONIX DEVELOPMENT CORP. 5154 ENTERPRISE BLVD. TOLEDO, OH 43612 US Other 510(k) Applications for this Company
Contact	JAMES HUTTNER Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/2012
Decision Date	03/07/2013
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