FDA 510(k) Application Details - K972865

Device Classification Name	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece   More FDA Info for this Device
510(K) Number	K972865
Device Name	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Applicant	PROMEX, INC. 1125 BROOKSIDE AVE. SUITE G500 INDIANAPOLIS, IN 46202 US Other 510(k) Applications for this Company
Contact	JOSEPH L MARK 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	08/04/1997
Decision Date	09/29/1997
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