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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 K151054
Device Name Coldplay Full CryoBalloon Ablation System and Coldplay Swipe 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 Received04/20/2015
Decision Date 07/07/2015
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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