FDA 510(k) Application Details - K983478

Device Classification Name	Tampon, Menstrual, Unscented   More FDA Info for this Device
510(K) Number	K983478
Device Name	Tampon, Menstrual, Unscented
Applicant	ORGANIC ESSENTIALS 822 BALDRIDGE ST. O'DONNELL, TX 79351 US Other 510(k) Applications for this Company
Contact	LA RHEA PEPPER 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	10/02/1998
Decision Date	11/09/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review