FDA 510(k) Application Details - K223198

Device Classification Name	Port, Intraosseous, Implanted   More FDA Info for this Device
510(K) Number	K223198
Device Name	Port, Intraosseous, Implanted
Applicant	Bard Access Systems 605 North 5600 West Salt Lake City, UT 84116 US Other 510(k) Applications for this Company
Contact	Nasreen Al-Quaid Other 510(k) Applications for this Contact
Regulation Number	880.5570   More FDA Info for this Regulation Number
Classification Product Code	MHC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/13/2022
Decision Date	11/10/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review