FDA 510(k) Application Details - K202112

Device Classification Name	More FDA Info for this Device
510(K) Number	K202112
Device Name	Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece
Applicant	Storz Medical AG Lohstampfestrasse 8 Tagerwilen CH-8274 CH Other 510(k) Applications for this Company
Contact	Pavel Novak Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/30/2020
Decision Date	02/21/2021
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