FDA 510(k) Application Details - K050067

Device Classification Name Tampon, Menstrual, Scented, Deodorized

  More FDA Info for this Device
510(K) Number K050067
Device Name Tampon, Menstrual, Scented, Deodorized
Applicant FIRST QUALITY HYGIENIC, INC.
73 FRANKLIN TURNPIKE
ALLENDALE, NJ 07401 US
Other 510(k) Applications for this Company
Contact ROBERT J STAAB, PH.D.
Other 510(k) Applications for this Contact
Regulation Number 884.5460

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

  More FDA Info for this Product Code
Date Received 01/12/2005
Decision Date 02/01/2005
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