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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 K781700
Device Name IONOTPHORETIC APPLICATOR
Applicant
Mcghan Medical Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Mcghan Medical Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.5525
Classification Product Code
KTB  
Date Received10/10/1978
Decision Date 11/03/1978
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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