FDA 510(k) Application Details - K012464

Device Classification Name	Lavage, Jet   More FDA Info for this Device
510(K) Number	K012464
Device Name	Lavage, Jet
Applicant	ANDREAS PEIN MEDIZINTECHNIK GMBH 13605 WEST 7TH AVE. GOLDEN, CO 80401-4604 US Other 510(k) Applications for this Company
Contact	ROBERT N CLARK Other 510(k) Applications for this Contact
Regulation Number	880.5475   More FDA Info for this Regulation Number
Classification Product Code	FQH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2001
Decision Date	10/10/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review