FDA 510(k) Application Details - K033789

Device Classification Name	Patient Examination Glove, Specialty   More FDA Info for this Device
510(K) Number	K033789
Device Name	Patient Examination Glove, Specialty
Applicant	Cardinal Health 1500 WAUKEGAN RD. BLDG. WM MCGAW PARK, IL 60085 US Other 510(k) Applications for this Company
Contact	ERICA SETHI Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/2003
Decision Date	05/07/2004
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