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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Recalls CDRH Recalls
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