FDA 510(k) Application Details - K970015

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K970015
Device Name	Polymer Patient Examination Glove
Applicant	ECI MEDICAL TECHNOLOGIES, INC. 2 COOK RD. BRIDGEWATER, NOVA SCOTIA B4V 3W7 CA Other 510(k) Applications for this Company
Contact	MICHAEL FORER Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/1997
Decision Date	06/24/1997
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