FDA 510(k) Application Details - K083761

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K083761
Device Name	Latex Patient Examination Glove
Applicant	ALATECH HEALTHCARE, LLC. 1600 STATE DOCKS RD. EUFAULA, AL 36027 US Other 510(k) Applications for this Company
Contact	NEIL ANDERSON Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2008
Decision Date	07/22/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review