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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 K922839
Device Name MID-CANADA MEDICAL
Applicant
Mid-Canada Medical
5630 Tomken Rd.
Mississauga, Ontario,  CA L4W 1P4
Applicant Contact JANE BELROSE
Correspondent
Mid-Canada Medical
5630 Tomken Rd.
Mississauga, Ontario,  CA L4W 1P4
Correspondent Contact JANE BELROSE
Regulation Number890.5300
Classification Product Code
IMI  
Date Received06/12/1992
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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