FDA 510(k) Application Details - K220372

Device Classification Name Lancet, Blood

  More FDA Info for this Device
510(K) Number K220372
Device Name Lancet, Blood
Applicant Tianjin Huahong Technology Co., Ltd.
A01, Plant B, No. 278, Hangkong Road, Tianjin Pilot Free
Trade Zone(Air Port Industrial Park)
Tianjin 300308 CN
Other 510(k) Applications for this Company
Contact Yuan Ying
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 02/09/2022
Decision Date 05/17/2022
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