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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 K230551
Device Name Visual-ICE Cryoablation System
Applicant
Boston Scientific Corporation
One Scimed Place
Maple Grove,  MN  55311 -1566
Applicant Contact Amy McKinney
Correspondent
Boston Scientific Corporation
One Scimed Place
Maple Grove,  MN  55311 -1566
Correspondent Contact Amy McKinney
Regulation Number878.4350
Classification Product Code
GEH  
Date Received02/28/2023
Decision Date 08/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Clinical Trials NCT02511678
Reviewed by Third Party No
Combination Product No
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