FDA 510(k) Application Details - K983552

Device Classification Name	Pump, Portable, Aspiration (Manual Or Powered)   More FDA Info for this Device
510(K) Number	K983552
Device Name	Pump, Portable, Aspiration (Manual Or Powered)
Applicant	MEDELA, INC. 4610 PRIME PKWY. P.O. BOX 660 MCHENRY, IL 60050-7005 US Other 510(k) Applications for this Company
Contact	STEPHEN D SMITH 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	10/09/1998
Decision Date	01/07/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review