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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, Specific Uses
510(k) Number K790205
Device Name ELECTROAPPLICATOR MODEL C-1
Applicant
Mcg, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Mcg, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5525
Classification Product Code
KTB  
Date Received01/31/1979
Decision Date 03/19/1979
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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