FDA 510(k) Application Details - K021098

Device Classification Name	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece   More FDA Info for this Device
510(K) Number	K021098
Device Name	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Applicant	MRI DEVICES DAUM GMBH P.O. BOX 4331 CROFTON,, MD 21114 US Other 510(k) Applications for this Company
Contact	E. J SMITH Other 510(k) Applications for this Contact
Regulation Number	874.4250   More FDA Info for this Regulation Number
Classification Product Code	ERL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/04/2002
Decision Date	12/03/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review