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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 K895365
Device Name MD-2 IONTOPHORESIS UNIT
Applicant
R. A. Fischer Co. Corp.
517 Commercial St.
Glendale,  CA  91203
Applicant Contact VAN ORDEN
Correspondent
R. A. Fischer Co. Corp.
517 Commercial St.
Glendale,  CA  91203
Correspondent Contact VAN ORDEN
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received08/28/1989
Decision Date 06/26/1990
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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