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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 K210310
Device Name CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit
Applicant
Nuance Medical, LLC
5931 Sea Lion Place, Suite 113
Carlsbad,  CA  82010
Applicant Contact Neal Hartman
Correspondent
Nuance Medical, LLC
5931 Sea Lion Place, Suite 113
Carlsbad,  CA  82010
Correspondent Contact Neal Hartman
Regulation Number878.4350
Classification Product Code
GEH  
Date Received02/03/2021
Decision Date 10/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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