FDA 510(k) Application Details - K012515

Device Classification Name	System, Delivery, Allergen And Vaccine   More FDA Info for this Device
510(K) Number	K012515
Device Name	System, Delivery, Allergen And Vaccine
Applicant	PRECISION MEDICAL PRODUCTS, INC. 12 INDUSTRIAL WAY DENVER, PA 17517 US Other 510(k) Applications for this Company
Contact	RONALD D WOLFE Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LDH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/06/2001
Decision Date	09/19/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review