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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Ablation, Microwave And Accessories
510(k) Number K082819
FOIA Releasable 510(k) K082819
Device Name DERMATOLOGIC TREATMENT SYSTEM (DTS) G2
Applicant
Miramar Labs, Inc.
199 Jefferson Dr.
Menlo Park,  CA  94025
Applicant Contact Kathy O'Shaughnessy
Correspondent
Miramar Labs, Inc.
199 Jefferson Dr.
Menlo Park,  CA  94025
Correspondent Contact Kathy O'Shaughnessy
Regulation Number878.4400
Classification Product Code
NEY  
Date Received09/25/2008
Decision Date 03/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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