FDA 510(k) Application Details - K190492

Device Classification Name	Dislodger, Stone, Basket, Ureteral, Metal   More FDA Info for this Device
510(K) Number	K190492
Device Name	Dislodger, Stone, Basket, Ureteral, Metal
Applicant	Calcula Technologies, Inc 959 Peralta Ave San Francisco, CA 94110 US Other 510(k) Applications for this Company
Contact	Raymond Buzz Bonneau Other 510(k) Applications for this Contact
Regulation Number	876.4680   More FDA Info for this Regulation Number
Classification Product Code	FFL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/28/2019
Decision Date	07/18/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review