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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 K221897
Device Name Hydrozid Precise
Applicant
Bibawo Medical A/S
Klintehøj Vænge 6
Birkerød,  DK 3460
Applicant Contact Sandra Larsen
Correspondent
Bibawo Medical A/S
Klintehøj Vænge 6
Birkerød,  DK 3460
Correspondent Contact Sandra Larsen
Regulation Number878.4350
Classification Product Code
GEH  
Date Received06/30/2022
Decision Date 05/30/2023
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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