FDA 510(k) Application Details - K955808

Device Classification Name Cabinet, Moist Steam

  More FDA Info for this Device
510(K) Number K955808
Device Name Cabinet, Moist Steam
Applicant THERMIA, INC.
4200 WEST 76TH ST.
EDINA, MN 55435 US
Other 510(k) Applications for this Company
Contact STEVEN J DAFFER
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 12/22/1995
Decision Date 11/03/1997
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact