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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
510(k) Number K930186
Device Name INTERTRON 6000/6100
Applicant
Williams Healthcare Systems, LLC
14833 W. 95th St.
Lenexa,  KS  66215
Applicant Contact CRAIG SEYL
Correspondent
Williams Healthcare Systems, LLC
14833 W. 95th St.
Lenexa,  KS  66215
Correspondent Contact CRAIG SEYL
Regulation Number890.5300
Classification Product Code
IMI  
Date Received01/14/1993
Decision Date 07/02/1993
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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