FDA 510(k) Application Details - K211753

Device Classification Name Syringe, Antistick

  More FDA Info for this Device
510(K) Number K211753
Device Name Syringe, Antistick
Applicant Jiangxi Hongda Medical Equipment Group Ltd.
No. 39 South Shengli Road
Nanchang 331700 CN
Other 510(k) Applications for this Company
Contact Xiaohua Yang
Other 510(k) Applications for this Contact
Regulation Number 880.5860

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

  More FDA Info for this Product Code
Date Received 06/07/2021
Decision Date 10/14/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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