FDA 510(k) Application Details - K032331

Device Classification Name	Holder, Head, Neurosurgical (Skull Clamp)   More FDA Info for this Device
510(K) Number	K032331
Device Name	Holder, Head, Neurosurgical (Skull Clamp)
Applicant	PRO-MED INSTRUMENTS GMBH 1899 SAWYER LANE ALVA, FL 33920 US Other 510(k) Applications for this Company
Contact	JIM BAZZINOTTI Other 510(k) Applications for this Contact
Regulation Number	882.4460   More FDA Info for this Regulation Number
Classification Product Code	HBL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/29/2003
Decision Date	11/20/2003
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