FDA 510(k) Application Details - K034004

Device Classification Name	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece   More FDA Info for this Device
510(K) Number	K034004
Device Name	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Applicant	GYRUS ENT L.L.C. 2925 APPLING RD. BARTLETT, TN 38133 US Other 510(k) Applications for this Company
Contact	ALICIA FARAGE 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	12/24/2003
Decision Date	03/03/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review