FDA 510(k) Application Details - K083537

Device Classification Name	System, Ablation, Microwave And Accessories   More FDA Info for this Device
510(K) Number	K083537
Device Name	System, Ablation, Microwave And Accessories
Applicant	MEDWAVES INCORPORATED 16760 WEST BERNARDO DRIVE SAN DIEGO, CA 92127 US Other 510(k) Applications for this Company
Contact	TED ORMSBY Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	NEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/28/2008
Decision Date	01/15/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review