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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 K161202
Device Name C2 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 Received04/28/2016
Decision Date 01/05/2017
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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