FDA 510(k) Application Details - K981953

Device Classification Name	Tampon, Menstrual, Unscented   More FDA Info for this Device
510(K) Number	K981953
Device Name	Tampon, Menstrual, Unscented
Applicant	PARAGON TRADE BRANDS, INC. 73 FRANKLIN TPK. ALLENDALE, NJ 07401 US Other 510(k) Applications for this Company
Contact	ROBERT J STAAB 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	06/03/1998
Decision Date	08/18/1998
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