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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 K121059
Device Name SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM
Applicant
ZIMMER MEDIZINSYSTEMS GMBH
JUNKERSSTRASSE 9
NEU-ULM,  DE 89231
Applicant Contact ARMIN PETRASCHKA
Correspondent
TUV SUD AMERICA INC.
1775 OLD HIGHWAY 8 NW
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact ALEXANDER SCHAPOVALOV
Regulation Number890.5860
Classification Product Code
IMG  
Subsequent Product Codes
GZJ   IMI   IPF   LIH  
Date Received04/06/2012
Decision Date 08/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
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