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510(k) K103014

Device
MIRADRY SYSTEM
Applicant
MIRAMAR LABS, INC.
510(k) number
K103014
Product code
OUB  
Decision
Substantially Equivalent (SESE)
Decision date
2011-01-28
Date received
2010-10-13
Regulation
878.4400
Classification name
Instrument For Treatment Of Hyperhidrosis
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kathy O'Shaughnessy
Address
445 Indio Way Sunnyvale CA US 94085 94085

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OUB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K150419miraDry System MD4000Miramar Labs, Inc.2015-06-19
K131162MIRADRY SYSTEMMiramar Labs, Inc.2013-10-25

Legacy Summary#

summary

FDA Review#

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