FDA 510(k) Application Details - K061205

Device Classification Name	Pump, Portable, Aspiration (Manual Or Powered)   More FDA Info for this Device
510(K) Number	K061205
Device Name	Pump, Portable, Aspiration (Manual Or Powered)
Applicant	MEDELA AG LAETTICHSTRASSE 4B BAAR, ZUG CH-6341 CH Other 510(k) Applications for this Company
Contact	WERNER FREI Other 510(k) Applications for this Contact
Regulation Number	878.4780   More FDA Info for this Regulation Number
Classification Product Code	BTA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2006
Decision Date	06/21/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review