FDA 510(k) Application Details - K223243

Device Classification Name Lancet, Blood

  More FDA Info for this Device
510(K) Number K223243
Device Name Lancet, Blood
Applicant Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes, NJ 07417 US
Other 510(k) Applications for this Company
Contact Alexandra Kirby
Other 510(k) Applications for this Contact
Regulation Number 878.4800

  More FDA Info for this Regulation Number
Classification Product Code FMK
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 10/20/2022
Decision Date 12/16/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact