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510(k) K221897

Hydrozid Precise by Bibawo Medical A/S — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2023
Date Received
June 30, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryosurgical, Accessories
Device Class
Class II
Regulation Number
878.4350
Review Panel
SU
Submission Type

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