FDA 510(k) Application Details - K221625

Device Classification Name	Catheter, Retention Type, Balloon   More FDA Info for this Device
510(K) Number	K221625
Device Name	Catheter, Retention Type, Balloon
Applicant	Silq Technologies Corporation 323 Sunny Isles Blvd Sunny Isles Beach, FL 33160 US Other 510(k) Applications for this Company
Contact	Sigi Caron Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/06/2022
Decision Date	07/01/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review