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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 K935868
Device Name DYNAPHOR(TM) TWO
Applicant
Maxxim Medical
104 Industrial Blvd.
Sugar Land,  TX  77478
Applicant Contact ERNEST J HENLEY
Correspondent
Maxxim Medical
104 Industrial Blvd.
Sugar Land,  TX  77478
Correspondent Contact ERNEST J HENLEY
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received12/06/1993
Decision Date 03/15/1995
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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