FDA 510(k) Application Details - K991591

Device Classification Name	Restraint, Protective   More FDA Info for this Device
510(K) Number	K991591
Device Name	Restraint, Protective
Applicant	BIOPLASTICS 34655 MILLS RD. N. RIDGEVILLE, OH 44039 US Other 510(k) Applications for this Company
Contact	CLAIRE BORON 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	05/07/1999
Decision Date	07/29/1999
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