FDA 510(k) Application Details - K013976

Device Classification Name	Regulator, Vacuum   More FDA Info for this Device
510(K) Number	K013976
Device Name	Regulator, Vacuum
Applicant	BOEHRINGER LABORATORIES 500 E. WASHINGTON ST. NORRISTOWN, PA 19401 US Other 510(k) Applications for this Company
Contact	JOHN KARPOWICZ Other 510(k) Applications for this Contact
Regulation Number	880.6740   More FDA Info for this Regulation Number
Classification Product Code	KDP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/03/2001
Decision Date	01/08/2002
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