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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 K871869
Device Name MODIFIED USE FOR MODEL 6110A IONTOPHORETIC APPLI.
Applicant
Life-Tech Intl., Inc.
P.O. Box 36221
Houston,  TX  77236
Applicant Contact COATS, MD
Correspondent
Life-Tech Intl., Inc.
P.O. Box 36221
Houston,  TX  77236
Correspondent Contact COATS, MD
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received05/13/1987
Decision Date 08/11/1987
Decision Substantially Equivalent - With Drug (SESD)
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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