FDA 510(k) Application Details - K161862

Device Classification Name Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

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510(K) Number K161862
Device Name Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Applicant Zimmer MedizinSysteme GmbH
Junkersstrasse 9
Neu-Ulm 89231 DE
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Contact Armin Petraschka
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Regulation Number 890.5290

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Classification Product Code IMJ
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Date Received 07/06/2016
Decision Date 11/14/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K161862


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