FDA 510(k) Application Details - K110566

Device Classification Name	Vibrator For Therapeutic Use, Genital   More FDA Info for this Device
510(K) Number	K110566
Device Name	Vibrator For Therapeutic Use, Genital
Applicant	REFLEXONIC, LLC 611 WEST 5TH STREET THIRD FLOOR AUSTIN, TX 78701 US Other 510(k) Applications for this Company
Contact	CAROLINE TONTINI Other 510(k) Applications for this Contact
Regulation Number	884.5960   More FDA Info for this Regulation Number
Classification Product Code	KXQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/28/2011
Decision Date	06/24/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review