FDA 510(k) Application Details - K101241

Device Classification Name Lubricant, Patient, Vaginal, Latex Compatible

  More FDA Info for this Device
510(K) Number K101241
Device Name Lubricant, Patient, Vaginal, Latex Compatible
Applicant LIL DRUG STORE PRODUCTS, INC.
1201 CONTINENTAL PL. N.E.
CEDAR RAPIDS, IA 52402 US
Other 510(k) Applications for this Company
Contact PATRICIA L MILLER
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 05/04/2010
Decision Date 08/17/2010
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 Y
Expedited Review



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