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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 K982668
Device Name PHORESOR II,MODEL PM900
Applicant
Iomed, Inc.
3385 W. 1820 S.
Salt Lake City,  UT  84104
Applicant Contact W.TIM MILLER
Correspondent
Iomed, Inc.
3385 W. 1820 S.
Salt Lake City,  UT  84104
Correspondent Contact W.TIM MILLER
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received07/31/1998
Decision Date 03/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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