FDA 510(k) Application Details - K201877

Device Classification Name	Syringe, Irrigating (Non Dental)   More FDA Info for this Device
510(K) Number	K201877
Device Name	Syringe, Irrigating (Non Dental)
Applicant	SafKan, Inc. 1665 E 18th Street #205 Tucson, AZ 85719 US Other 510(k) Applications for this Company
Contact	Sahil Diwan Other 510(k) Applications for this Contact
Regulation Number	880.6960   More FDA Info for this Regulation Number
Classification Product Code	KYZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/07/2020
Decision Date	11/05/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review