FDA 510(k) Application Details - K131162

Device Classification Name

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510(K) Number K131162
Device Name MIRADRY SYSTEM
Applicant MIRAMAR LABS, INC.
445 INDIO WAY
SUNNYVALE, CA 94085-4203 US
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Contact Kathy O'Shaughnessy
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Regulation Number

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Classification Product Code OUB
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Date Received 04/24/2013
Decision Date 10/25/2013
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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