FDA 510(k) Application Details - K011308

Device Classification Name	Stimulator, Nerve, Battery-Powered   More FDA Info for this Device
510(K) Number	K011308
Device Name	Stimulator, Nerve, Battery-Powered
Applicant	PAJUNK GMBH 203 MAIN STREET, PMB 166 FLEMINGTON,, NJ 08822 US Other 510(k) Applications for this Company
Contact	LYNETTE HOWARD Other 510(k) Applications for this Contact
Regulation Number	868.2775   More FDA Info for this Regulation Number
Classification Product Code	BXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2001
Decision Date	11/29/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review