FDA 510(k) Application Details - K980053

Device Classification Name	Band, Elastic, Orthodontic   More FDA Info for this Device
510(K) Number	K980053
Device Name	Band, Elastic, Orthodontic
Applicant	GLENROE TECHNOLOGIES 1912 44TH AVE., EAST BRADENTON, FL 34203 US Other 510(k) Applications for this Company
Contact	JOHN BOZMAN Other 510(k) Applications for this Contact
Regulation Number	872.5410   More FDA Info for this Regulation Number
Classification Product Code	ECI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/06/1998
Decision Date	02/24/1998
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