Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K193449
Device Classification Name
Pump, Breast, Powered
More FDA Info for this Device
510(K) Number
K193449
Device Name
Pump, Breast, Powered
Applicant
Guangdong Horigen Mother & Baby Products Co., Ltd
No. 18, Pingnan Industrial Zone, Mianbei Street,
Chaoyang District
Shantou 515100 CN
Other 510(k) Applications for this Company
Contact
Jun Deng
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
12/13/2019
Decision Date
09/11/2020
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