FDA 510(k) Application Details - K984035

Device Classification Name	Drills, Burrs, Trephines & Accessories (Simple, Powered)   More FDA Info for this Device
510(K) Number	K984035
Device Name	Drills, Burrs, Trephines & Accessories (Simple, Powered)
Applicant	KOMET MEDICAL 1679 KELLOGG SPRINGS DR. ATLANTA, GA 30338 US Other 510(k) Applications for this Company
Contact	COURTNEY S PARADICE Other 510(k) Applications for this Contact
Regulation Number	882.4310   More FDA Info for this Regulation Number
Classification Product Code	HBE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/1998
Decision Date	06/03/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review