FDA 510(k) Application Details - K970135

Device Classification Name	Patient Examination Glove, Specialty   More FDA Info for this Device
510(K) Number	K970135
Device Name	Patient Examination Glove, Specialty
Applicant	SAGE PRODUCTS, INC. 815 TEK DR. CRYSTAL LAKE, IL 60014-8172 US Other 510(k) Applications for this Company
Contact	KAREN PINTO 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	01/15/1997
Decision Date	08/25/1997
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