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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
510(k) Number K934846
Device Name SONICATOR 716
Applicant
Mettler Electronics Corp.
1333 S. Claudina St.
Anaheim,  CA  92805
Applicant Contact ROBERT E FLEMING
Correspondent
Mettler Electronics Corp.
1333 S. Claudina St.
Anaheim,  CA  92805
Correspondent Contact ROBERT E FLEMING
Regulation Number890.5860
Classification Product Code
IMG  
Date Received10/08/1993
Decision Date 03/23/1994
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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