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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 K251928
Device Name CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)
Applicant
Medinice S.A.
S.K. Hankiewicza
Warsaw,  PL 02-103
Applicant Contact Sanjeev Choudhary
Correspondent
MEDIcept
200 Homer Ave.,
Ashland,  MA  01721
Correspondent Contact Melissa DeHass
Regulation Number878.4350
Classification Product Code
GEH  
Date Received06/23/2025
Decision Date 02/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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