FDA 510(k) Application Details - K963489

Device Classification Name	Restraint, Protective   More FDA Info for this Device
510(K) Number	K963489
Device Name	Restraint, Protective
Applicant	SMITH AND NEPHEW DONJOY, INC. 2985 SCOTT ST. VISTA, CA 92083 US Other 510(k) Applications for this Company
Contact	DAN W MILLER 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	09/03/1996
Decision Date	11/12/1996
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