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FDA Product Code

FDA Product Code OUB — Clearance Directory

Device Class
Class II
21 CFR Citation
878.4400

510(k) Clearances — 3 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K150419 miraDry System MD4000 Miramar Labs, Inc. 2015-06-19 Traditional PDF ↗
K131162 MIRADRY SYSTEM Miramar Labs, Inc. 2013-10-25 Traditional PDF ↗
K103014 MIRADRY SYSTEM Miramar Labs, Inc. 2011-01-28 Traditional PDF ↗

Product code OUB · Class II · General, Plastic Surgery. Data: openFDA.