FDA 510(k) Application Details - K981637

Device Classification Name	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece   More FDA Info for this Device
510(K) Number	K981637
Device Name	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Applicant	LINVATEC CORP. 11311 CONCEPT BLVD. LARGO, FL 33773-4908 US Other 510(k) Applications for this Company
Contact	CAROL A WEIDEMAN 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	05/08/1998
Decision Date	07/20/1998
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