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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
510(k) Number K120093
Device Name BTL ELITE
Applicant
BTL Industries, Inc.
16 Appleton St.
Waltham,  MA  02453
Applicant Contact Marcy Moore
Correspondent
BTL Industries, Inc.
16 Appleton St.
Waltham,  MA  02453
Correspondent Contact Marcy Moore
Regulation Number890.5290
Classification Product Code
IMJ  
Date Received01/12/2012
Decision Date 10/05/2012
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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