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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 K142441
Device Name cryoICE croablation probe
Applicant
ATRICURE, INC.
6217 CENTER PARK DRIVE
WEST CHESTER,  OH  45069
Applicant Contact Jonathan McElwee
Correspondent
ATRICURE, INC.
6217 CENTER PARK DRIVE
WEST CHESTER,  OH  45069
Correspondent Contact Jonathan McElwee
Regulation Number878.4350
Classification Product Code
GEH  
Date Received09/02/2014
Decision Date 10/29/2014
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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