FDA 510(k) Application Details - K964810

Device Classification Name	Unit, Oral Irrigation   More FDA Info for this Device
510(K) Number	K964810
Device Name	Unit, Oral Irrigation
Applicant	ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH SOUTH JORDAN, UT 84095 US Other 510(k) Applications for this Company
Contact	CHESTER MCCOY 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	11/29/1996
Decision Date	02/10/1997
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