FDA 510(k) Application Details - K003745

Device Classification Name	Stimulator, Nerve   More FDA Info for this Device
510(K) Number	K003745
Device Name	Stimulator, Nerve
Applicant	RLN SYSTEMS, INC. 2019 HONEYSUCKLE LN. P.O. BOX 6757 JEFFERSON CITY, MO 65109 US Other 510(k) Applications for this Company
Contact	J. LEE REA Other 510(k) Applications for this Contact
Regulation Number	874.1820   More FDA Info for this Regulation Number
Classification Product Code	ETN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/2000
Decision Date	01/16/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review