Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Cabinet, Moist Steam
510(k) Number K003916
Device Name DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM
Applicant
SCANDIA MANUFACTURING LTD.
9220 JAMES AVENUE SOUTH
BLOOMINGTON,  MN  55431
Applicant Contact RONALD E BERGLUND
Correspondent
SCANDIA MANUFACTURING LTD.
9220 JAMES AVENUE SOUTH
BLOOMINGTON,  MN  55431
Correspondent Contact RONALD E BERGLUND
Regulation Number890.5250
Classification Product Code
IMB  
Date Received12/19/2000
Decision Date 04/15/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-