Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K153016
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K153016
Device Name
Condom
Applicant
Guangzhou Daming United Rubber Products Ltd.
NO. 1 Daming Street, Port Industrial Zone Huada District
Guangzhou 510802 CN
Other 510(k) Applications for this Company
Contact
Yongbing Xie
Other 510(k) Applications for this Contact
Regulation Number
884.5300
More FDA Info for this Regulation Number
Classification Product Code
HIS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/15/2015
Decision Date
10/20/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact