FDA 510(k) Application Details - K982178

Device Classification Name	Restraint, Protective   More FDA Info for this Device
510(K) Number	K982178
Device Name	Restraint, Protective
Applicant	EMERGENT INNOVATIONS, LTD. PO BOX 40773 INDIANAPOLIS, IN 46240 US Other 510(k) Applications for this Company
Contact	DUANE R ELLIOTT Other 510(k) Applications for this Contact
Regulation Number	880.6760   More FDA Info for this Regulation Number
Classification Product Code	FMQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/22/1998
Decision Date	01/26/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review