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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 K991613
Device Name SW ULTRASOUND, MODELS 331, 311, 333
Applicant
Starbene
David Luque 519
Cordoba, Pvcia. Cordoba,  AR 5000
Applicant Contact JUDITH NIZTZSCHMAMN
Correspondent
Starbene
David Luque 519
Cordoba, Pvcia. Cordoba,  AR 5000
Correspondent Contact JUDITH NIZTZSCHMAMN
Regulation Number890.5300
Classification Product Code
IMI  
Date Received05/10/1999
Decision Date 12/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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