510(k) K242288

Advanced Cryo Wart Remover by Medical Brands Laboratories B.V. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2025
Date Received
August 2, 2024
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