FDA 510(k) Application Details - K190651

Device Classification Name	Unit, Cryosurgical, Accessories   More FDA Info for this Device
510(K) Number	K190651
Device Name	Unit, Cryosurgical, Accessories
Applicant	Erbe Elektromedizin GmbH Waldhoernlestrasse 17 Tuebingen 72072 DE Other 510(k) Applications for this Company
Contact	Julia Weller 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	03/13/2019
Decision Date	01/07/2020
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