FDA 510(k) Application Details - K101413

Device Classification Name

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510(K) Number K101413
Device Name EUROMI EVA SP6
Applicant EUROMI SA
80 SHELTON TECHNOLOGY CENTER
SHELTON, CT 06484 US
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Contact CURTIS RAYMOND
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Regulation Number

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Classification Product Code QPB
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Date Received 05/20/2010
Decision Date 12/16/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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