FDA 510(k) Application Details - K212705

Device Classification Name

  More FDA Info for this Device
510(K) Number K212705
Device Name Actively Trying Personal Lubricant Unfragrance
Applicant CC Wellness LLC
29000 N. Hancock Pkwy.
Valencia, CA 91355 US
Other 510(k) Applications for this Company
Contact Marlent Perez
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 08/26/2021
Decision Date 02/09/2022
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

FDA Source Information for K212705


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