FDA 510(k) Application Details - K222547

Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)

  More FDA Info for this Device
510(K) Number K222547
Device Name Pump, Portable, Aspiration (Manual Or Powered)
Applicant Shenzhen XinLianFeng Technology CO.,LTD
No.5, Tongxi Road, Pingdong Community, Pingdi Street,
Longgang District
Shenzhen 518000 CN
Other 510(k) Applications for this Company
Contact Ma Qiang
Other 510(k) Applications for this Contact
Regulation Number 878.4780

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

  More FDA Info for this Product Code
Date Received 08/23/2022
Decision Date 10/20/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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