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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
510(k) Number K861247
Device Name CURAMED 402 DIATHERMY UNIT
Applicant
Henley Intl.
10518 Kinghurst
Houston,  TX  77099
Applicant Contact DAVIS C HENLEY
Correspondent
Henley Intl.
10518 Kinghurst
Houston,  TX  77099
Correspondent Contact DAVIS C HENLEY
Regulation Number890.5290
Classification Product Code
IMJ  
Date Received04/02/1986
Decision Date 05/30/1986
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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