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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 K842483
Device Name SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC
Applicant
Santa Barbara Medco, Inc.
P.O. Box 6843
Santa Barbara,  CA  93111
Applicant Contact David G Esslinger
Correspondent
Santa Barbara Medco, Inc.
P.O. Box 6843
Santa Barbara,  CA  93111
Correspondent Contact David G Esslinger
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received06/25/1984
Decision Date 08/31/1984
Decision Substantially Equivalent (SESE)
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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