FDA 510(k) Application Details - K072236

Device Classification Name Lubricant, Patient, Vaginal, Latex Compatible

  More FDA Info for this Device
510(K) Number K072236
Device Name Lubricant, Patient, Vaginal, Latex Compatible
Applicant SSL AMERICAS
3585 ENGINEERING DR.
NORCROSS, GA 30092 US
Other 510(k) Applications for this Company
Contact CHRIS ROBINSON
Other 510(k) Applications for this Contact
Regulation Number 884.5300

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

  More FDA Info for this Product Code
Date Received 08/10/2007
Decision Date 05/07/2008
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