Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K182585
Device Classification Name
More FDA Info for this Device
510(K) Number
K182585
Device Name
JO Actively Trying Personal Lubricant
Applicant
United Consortium
29000 N. Hancock Pkwy.
Valencia, CA 91355 US
Other 510(k) Applications for this Company
Contact
Stephanie Morris
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PEB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/20/2018
Decision Date
04/26/2019
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