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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Iontophoresis, Other Uses
510(k) Number K072946
Device Name HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM
Applicant
Empi
599 Cardigan Rd.
St. Paul,  MN  55126
Applicant Contact SANDRA WALROD
Correspondent
Empi
599 Cardigan Rd.
St. Paul,  MN  55126
Correspondent Contact SANDRA WALROD
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received10/17/2007
Decision Date 11/16/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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