FDA 510(k) Application Details - K021864

Device Classification Name	Drape, Surgical   More FDA Info for this Device
510(K) Number	K021864
Device Name	Drape, Surgical
Applicant	PRIMELINE MEDICAL PRODUCTS, INC. 10707 100TH AVE., SUITE 300 EDMONTON, ALBERTA T5J 3M1 CA Other 510(k) Applications for this Company
Contact	BRENDA LEE Other 510(k) Applications for this Contact
Regulation Number	878.4370   More FDA Info for this Regulation Number
Classification Product Code	KKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/06/2002
Decision Date	09/23/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review