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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, cryosurgical, accessories
510(k) Number K153541
Device Name Coldplay CryoBalloon® Ablation System
Applicant
C2 THERAPEUTICS, INC.
303 CONVENTION WAY, SUITE 1
REDWOOD CITY,  CA  94063
Applicant Contact THERESA BRANDNER-ALLEN
Correspondent
C2 THERAPEUTICS, INC.
303 CONVENTION WAY, SUITE 1
REDWOOD CITY,  CA  94063
Correspondent Contact THERESA BRANDNER-ALLEN
Regulation Number878.4350
Classification Product Code
GEH  
Date Received12/10/2015
Decision Date 01/07/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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