FDA 510(k) Application Details - K981808

Device Classification Name	Scraper, Tongue   More FDA Info for this Device
510(K) Number	K981808
Device Name	Scraper, Tongue
Applicant	BREATHAID, LLC. KEENAN BLDG., 3RD FLOOR 1330 LADY STREET COLUMBIA, SC 29211 US Other 510(k) Applications for this Company
Contact	J. DOUGLAS NUNN, JR. Other 510(k) Applications for this Contact
Regulation Number	872.6855   More FDA Info for this Regulation Number
Classification Product Code	LCN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/1998
Decision Date	08/11/1998
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