FDA 510(k) Application Details - K973495

Device Classification Name	Band, Elastic, Orthodontic   More FDA Info for this Device
510(K) Number	K973495
Device Name	Band, Elastic, Orthodontic
Applicant	GLENROE 1912 44TH AVENUE E. 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	09/16/1997
Decision Date	12/01/1997
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