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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 K201740
Device Name Hydrozid
Applicant
Medilink A/S
Gammelmosevej 176a
Kgs. Lyngby,  DK 2800
Applicant Contact Cristina Teixeira
Correspondent
Medilink A/S
Gammelmosevej 176a
Kgs. Lyngby,  DK 2800
Correspondent Contact Cristina Teixeira
Regulation Number878.4350
Classification Product Code
GEH  
Date Received06/25/2020
Decision Date 07/07/2021
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
Predetermined Change
Control Plan Authorized		 No
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