FDA 510(k) Application Details - K090098

Device Classification Name	Tampon, Menstrual, Unscented   More FDA Info for this Device
510(K) Number	K090098
Device Name	Tampon, Menstrual, Unscented
Applicant	MAXIM HYGIENE PRODUCTS, INC. 1468 HARWELL AVE. CROFTON, MD 21114 US Other 510(k) Applications for this Company
Contact	E.J. Smith Other 510(k) Applications for this Contact
Regulation Number	884.5470   More FDA Info for this Regulation Number
Classification Product Code	HEB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/15/2009
Decision Date	01/30/2009
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