FDA 510(k) Application Details - K974649

Device Classification Name	Post, Root Canal   More FDA Info for this Device
510(K) Number	K974649
Device Name	Post, Root Canal
Applicant	ADVANCED AEROMEDICAL, INC. 55 NORTHERN BLVD. SUITE 410 GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	CAROLANN KOTULA Other 510(k) Applications for this Contact
Regulation Number	872.3810   More FDA Info for this Regulation Number
Classification Product Code	ELR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/1997
Decision Date	05/01/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review