FDA 510(k) Application Details - K012057

Device Classification Name	Bath, Hydro-Massage   More FDA Info for this Device
510(K) Number	K012057
Device Name	Bath, Hydro-Massage
Applicant	PENNER MANUFACTURING, INC. 1500 WOODMEN TOWER OHAHA, NE 68102 US Other 510(k) Applications for this Company
Contact	VICKIE J BRADY 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	07/02/2001
Decision Date	07/19/2001
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	Y
Expedited Review