FDA 510(k) Application Details - K242288

Device Classification Name	Unit, Cryosurgical, Accessories   More FDA Info for this Device
510(K) Number	K242288
Device Name	Unit, Cryosurgical, Accessories
Applicant	Medical Brands Laboratories B.V. Weesperstraat 114 Diemen 1112AP NL Other 510(k) Applications for this Company
Contact	Pieternella Bouter Other 510(k) Applications for this Contact
Regulation Number	878.4350   More FDA Info for this Regulation Number
Classification Product Code	GEH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/02/2024
Decision Date	01/21/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review