FDA 510(k) Application Details - K240226

Device Classification Name	Cryogenic, Skin Tag Removal, Otc   More FDA Info for this Device
510(K) Number	K240226
Device Name	Cryogenic, Skin Tag Removal, Otc
Applicant	Oystershell NV Nijverheidsweg 10 Merelbeke 9820 BE Other 510(k) Applications for this Company
Contact	Laurens De Schepper Other 510(k) Applications for this Contact
Regulation Number	878.4350   More FDA Info for this Regulation Number
Classification Product Code	ORE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/26/2024
Decision Date	10/18/2024
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