FDA 510(k) Application Details - K121059

Device Classification Name Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

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510(K) Number K121059
Device Name Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Applicant ZIMMER MEDIZINSYSTEMS GMBH
JUNKERSSTRASSE 9
NEU-ULM 89231 DE
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Contact ARMIN PETRASCHKA
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Regulation Number 890.5860

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Classification Product Code IMG
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Date Received 04/06/2012
Decision Date 08/07/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party Y
Expedited Review



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