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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 K941567
Device Name DIATHERMY DEVICE-MICROFOCUS
Applicant
CHEUNG LABORATORIES, INC.
10220 - I OLD COLUMBIA RD.
COLUMBIA,  MD  21046 -1890
Applicant Contact DENNIS SMITH
Correspondent
CHEUNG LABORATORIES, INC.
10220 - I OLD COLUMBIA RD.
COLUMBIA,  MD  21046 -1890
Correspondent Contact DENNIS SMITH
Regulation Number890.5275
Classification Product Code
IOA  
Date Received04/01/1994
Decision Date 04/22/1996
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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