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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 K850508
Device Name LOGIKAL LONTOPHORESIS UNIT -ANESTHESIA INOTOPHORES
Applicant
Kal Life Systems
24581 Saturna
Mission Viejo,  CA  92691
Applicant Contact WILLIAM THURMAN
Correspondent
Kal Life Systems
24581 Saturna
Mission Viejo,  CA  92691
Correspondent Contact WILLIAM THURMAN
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received02/08/1985
Decision Date 05/15/1985
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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