FDA 510(k) Application Details - K971319

Device Classification Name	File, Pulp Canal, Endodontic   More FDA Info for this Device
510(K) Number	K971319
Device Name	File, Pulp Canal, Endodontic
Applicant	TYCOM DENTAL 18140 SMOKESIGNAL DR. SAN DIEGO, CA 92127 US Other 510(k) Applications for this Company
Contact	CAROL PATTERSON Other 510(k) Applications for this Contact
Regulation Number	872.4565   More FDA Info for this Regulation Number
Classification Product Code	EKS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/10/1997
Decision Date	05/22/1997
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