FDA 510(k) Application Details - K983374

Device Classification Name	Unit, Oral Irrigation   More FDA Info for this Device
510(K) Number	K983374
Device Name	Unit, Oral Irrigation
Applicant	MIDIAN INTL. 5821 NW 28TH ST. LAUDERHILL, FL 33313 US Other 510(k) Applications for this Company
Contact	CHRIS MONTALBANO Other 510(k) Applications for this Contact
Regulation Number	872.6510   More FDA Info for this Regulation Number
Classification Product Code	EFS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/1998
Decision Date	12/23/1998
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