FDA 510(k) Application Details - K971593

Device Classification Name	Bath, Hydro-Massage   More FDA Info for this Device
510(K) Number	K971593
Device Name	Bath, Hydro-Massage
Applicant	THE SILCRAFT CORP. 555 THIRTEENTH ST., N.W. WASHINGTON, DC 20004-1109 US Other 510(k) Applications for this Company
Contact	HOWARD M HOLSTEIN 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	05/01/1997
Decision Date	02/26/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review