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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 K884834
Device Name XOMED IONESTHETIZER(TM)
Applicant
Xomed, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Applicant Contact GORDON PETERS
Correspondent
Xomed, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Correspondent Contact GORDON PETERS
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received11/18/1988
Decision Date 02/15/1989
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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