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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 K923076
Device Name ULTRA SX
Applicant
Excel Tech. , Ltd.
2892 Portland Dr.
Oakville,Ontario,  CA L6H 5W8
Applicant Contact JOHN MUMFORD
Correspondent
Excel Tech. , Ltd.
2892 Portland Dr.
Oakville,Ontario,  CA L6H 5W8
Correspondent Contact JOHN MUMFORD
Regulation Number890.5300
Classification Product Code
IMI  
Date Received06/25/1992
Decision Date 03/09/1993
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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