FDA 510(k) Application Details - K183438

Device Classification Name	Dilator, Vessel, Surgical   More FDA Info for this Device
510(K) Number	K183438
Device Name	Dilator, Vessel, Surgical
Applicant	Geomed Medizin-Technik GmbH & Co. Ludwigstaler Strasse 27 Tuttlingen 78532 DE Other 510(k) Applications for this Company
Contact	Hanno Haug Other 510(k) Applications for this Contact
Regulation Number	870.4475   More FDA Info for this Regulation Number
Classification Product Code	DWP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2018
Decision Date	09/03/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review