FDA 510(k) Application Details - K003916

Device Classification Name	Cabinet, Moist Steam   More FDA Info for this Device
510(K) Number	K003916
Device Name	Cabinet, Moist Steam
Applicant	SCANDIA MANUFACTURING LTD. 9220 JAMES AVENUE SOUTH BLOOMINGTON, MN 55431 US Other 510(k) Applications for this Company
Contact	RONALD E BERGLUND Other 510(k) Applications for this Contact
Regulation Number	890.5250   More FDA Info for this Regulation Number
Classification Product Code	IMB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/19/2000
Decision Date	04/15/2002
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