FDA 510(k) Application Details - K223329

Device Classification Name Pump, Breast, Powered

  More FDA Info for this Device
510(K) Number K223329
Device Name Pump, Breast, Powered
Applicant Guangzhou Yongyi Industrial Co., Ltd.
No. 4, Majun Rd., Dongchong Town, Nansha District
Guangzhou 523000 CN
Other 510(k) Applications for this Company
Contact Wei Hu
Other 510(k) Applications for this Contact
Regulation Number 884.5160

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

  More FDA Info for this Product Code
Date Received 10/31/2022
Decision Date 05/26/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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