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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 K914264
Device Name TRANSQ 2
Applicant
Iomed, Inc.
1290 W. 2320 S., Suite A
Salt Lake City,  UT  84119
Applicant Contact ANNE T CARTER
Correspondent
Iomed, Inc.
1290 W. 2320 S., Suite A
Salt Lake City,  UT  84119
Correspondent Contact ANNE T CARTER
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received09/23/1991
Decision Date 12/20/1991
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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