FDA 510(k) Applications for Medical Device Product Code: FXP (Cover, Shoe, Operating-Room)

FDA 510(k) Applications for Medical Device Product Code "FXP"
(Cover, Shoe, Operating-Room)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K970815	ALLEGIANCE HEALTHCARE CORP.	CONVERTORS IMPERVIOUS SHOE COVERS	03/27/1997
K961342	COPIOUMED INTL., INC.	SHOE COVER, NON-STERILE	12/30/1996
K971191	FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD	FAR-EAST SHOE COVERS	07/10/1997
K955835	INSTRUMENT MAKAR, INC.	FLUID BARRIER BOOT KNEE & ANKLE-HIGH	11/19/1996
K971076	PRIMELINE MEDICAL PRODUCTS, INC.	PRIMED SHOE COVERS, PRIMED HEAD COVERS	01/13/1998