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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 K915444
Device Name DUPEL IONTOPHORESIS DEVICE
Applicant
Empi
1275 Grey Fox Rd.
Arden Hills,  MN  55112
Applicant Contact STACY MATTSON
Correspondent
Empi
1275 Grey Fox Rd.
Arden Hills,  MN  55112
Correspondent Contact STACY MATTSON
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received12/05/1991
Decision Date 07/15/1994
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
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