FDA 510(k) Application Details - K982991

Device Classification Name	Drills, Burrs, Trephines & Accessories (Compound, Powered)   More FDA Info for this Device
510(K) Number	K982991
Device Name	Drills, Burrs, Trephines & Accessories (Compound, Powered)
Applicant	THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. PALM BEACH GARDENS, FL 33410 US Other 510(k) Applications for this Company
Contact	LISA KREIDER Other 510(k) Applications for this Contact
Regulation Number	882.4305   More FDA Info for this Regulation Number
Classification Product Code	HBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/27/1998
Decision Date	10/21/1998
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