FDA 510(k) Application Details - K150419

Device Classification Name	More FDA Info for this Device
510(K) Number	K150419
Device Name	miraDry System MD4000
Applicant	MIRAMAR LABS, INC. 2790 WALSH AVENUE SANTA CLARA, CA 95051 US Other 510(k) Applications for this Company
Contact	KATHY O'SHAUGHNESSY Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/18/2015
Decision Date	06/19/2015
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