FDA 510(k) Application Details - K111557

Device Classification Name	Stimulator, Electrical, Transcutaneous, For Arthritis   More FDA Info for this Device
510(K) Number	K111557
Device Name	Stimulator, Electrical, Transcutaneous, For Arthritis
Applicant	SEVEN SEAS DISTRIBTION AND MANUFACTURING LLC 2620 S MARYLAND PKWY STE 14 UNIT 835 LAS VEGAS, NV 89109 US Other 510(k) Applications for this Company
Contact	MARK IOELE Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	NYN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/03/2011
Decision Date	11/10/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review