FDA 510(k) Application Details - K973175

Device Classification Name	Scraper, Tongue   More FDA Info for this Device
510(K) Number	K973175
Device Name	Scraper, Tongue
Applicant	SOFTEK ENT. 5245 SOUTH HANOVER WAY ENGLEWOOD, CO 80111 US Other 510(k) Applications for this Company
Contact	PROMILA GUPTA 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	08/25/1997
Decision Date	10/14/1997
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