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FDA 510(k) Application Details - K150419
Device Classification Name
More FDA Info for this Device
510(K) Number
K150419
Device Name
miraDry System MD4000
Applicant
MIRAMAR LABS, INC.
2790 WALSH AVENUE
SANTA CLARA, CA 95051 US
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Contact
KATHY O'SHAUGHNESSY
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
OUB
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Date Received
02/18/2015
Decision Date
06/19/2015
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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