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510(k) K210529

Dr. Yglo Wart Remover by Theotclab Healthcare B.V. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2021
Date Received
February 23, 2021
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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