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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, Specific Uses
510(k) Number K001522
Device Name TRANSQ3
Applicant
IOMED, INC.
3385 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Applicant Contact W. TIM MILLER
Correspondent
IOMED, INC.
3385 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Correspondent Contact W. TIM MILLER
Regulation Number890.5525
Classification Product Code
KTB  
Date Received05/16/2000
Decision Date 10/18/2000
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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