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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 K180137
Device Name AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)
Applicant
AtriCure, Inc.
7555 Innovation Way
Mason,  OH  45040
Applicant Contact Melissa Smallwood
Correspondent
AtriCure, Inc.
7555 Innovation Way
Mason,  OH  45040
Correspondent Contact Melissa Smallwood
Regulation Number878.4350
Classification Product Code
GEH  
Date Received01/17/2018
Decision Date 02/15/2018
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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