FDA 510(k) Application Details - K003662

Device Classification Name	Tong, Skull For Traction   More FDA Info for this Device
510(K) Number	K003662
Device Name	Tong, Skull For Traction
Applicant	SPINE WORKS 10170 E. CHERRY BEND RD. TRAVERSE CITY, MI 49684 US Other 510(k) Applications for this Company
Contact	DAN FARLEY Other 510(k) Applications for this Contact
Regulation Number	882.5960   More FDA Info for this Regulation Number
Classification Product Code	HAX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/28/2000
Decision Date	07/09/2001
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