FDA 510(k) Application Details - K980909

Device Classification Name	Bath, Hydro-Massage   More FDA Info for this Device
510(K) Number	K980909
Device Name	Bath, Hydro-Massage
Applicant	BOUVIER HYDRO, INC. 100 WALNUT ST. SUITE 20 P.O. BOX 2874 CHAMPLAIN,, NY 12919 US Other 510(k) Applications for this Company
Contact	JOYCE M DUQUETTE Other 510(k) Applications for this Contact
Regulation Number	890.5100   More FDA Info for this Regulation Number
Classification Product Code	ILJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/10/1998
Decision Date	08/11/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review