FDA 510(k) Application Details - K001640

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K001640
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	BIOSOFT INTERNATIONAL CORP. 944 WILLIAMS ST. TRENTON, NJ 08610 US Other 510(k) Applications for this Company
Contact	ROY SHU Other 510(k) Applications for this Contact
Regulation Number	872.3760   More FDA Info for this Regulation Number
Classification Product Code	EBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/08/2000
Decision Date	06/23/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review