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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 K913601
Device Name MICROPHOR
Applicant
Life-Tech Intl., Inc.
P.O. Box 36221
Houston,  TX  77236
Applicant Contact ALFRED C COATS
Correspondent
Life-Tech Intl., Inc.
P.O. Box 36221
Houston,  TX  77236
Correspondent Contact ALFRED C COATS
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received08/13/1991
Decision Date 07/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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