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510(k) K103014

MIRADRY SYSTEM by Miramar Labs, Inc. — Product Code OUB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 28, 2011
Date Received: October 13, 2010
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Instrument For Treatment Of Hyperhidrosis
Device Class: Class II
Regulation Number: 878.4400
Review Panel: SU
Submission Type

Soft-tissue coagulation