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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 K150353
Device Name BTL-4000
Applicant
BTL INDUSTRIES, INC
47 Loring Drive
Framingham,  MA  01702
Applicant Contact Jan Zarsky
Correspondent
BTL INDUSTRIES, INC
47 Loring Drive
Framington,  MA  01702
Correspondent Contact Jan Zarsky
Regulation Number890.5860
Classification Product Code
IMG  
Subsequent Product Codes
GZI   GZJ   ILY   IPF   LIH  
Date Received02/11/2015
Decision Date 11/13/2015
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
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