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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat
510(k) Number K860082
Device Name THERMOTRON 918
Applicant
Medical Microwave Research Corp.
808 Pershing Dr. Suite 104
Silver Spring,  MD  20910
Applicant Contact LAWRENCE E LARSEN
Correspondent
Medical Microwave Research Corp.
808 Pershing Dr. Suite 104
Silver Spring,  MD  20910
Correspondent Contact LAWRENCE E LARSEN
Regulation Number890.5275
Classification Product Code
IOA  
Date Received01/08/1986
Decision Date 03/27/1986
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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