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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 K152329
Device Name Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe 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 Received08/18/2015
Decision Date 04/13/2016
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
Recalls CDRH Recalls
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