FDA 510(k) Application Details - K013239

Device Classification Name	Restraint, Protective   More FDA Info for this Device
510(K) Number	K013239
Device Name	Restraint, Protective
Applicant	MED GEN, INC. 7284 W. PALMETTO PK. RD. BOCA RATON, FL 33433-3406 US Other 510(k) Applications for this Company
Contact	THEODORE BARASH 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	09/28/2001
Decision Date	11/20/2001
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