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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 K912015
Device Name TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3
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 Received05/06/1991
Decision Date 11/15/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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