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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 Pl.
Maple Grove,  MN  55311
Applicant Contact Amy McKinney
Correspondent
Boston Scientific Corporation
One Scimed Pl.
Maple Grove,  MN  55311
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
Predetermined Change
Control Plan Authorized		 No
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