FDA 510(k) Application Details - K954445

Device Classification Name	Tampon, Menstrual, Unscented   More FDA Info for this Device
510(K) Number	K954445
Device Name	Tampon, Menstrual, Unscented
Applicant	HYGIEIA HEALTHCARE LTD. UNIT 2 SUNRISE ENTERPRISE PARK FERRYBOAT LANE CASTLETOWN, SUNDERLAND SR5 3RX SR5 3RX GB Other 510(k) Applications for this Company
Contact	PETER BRENIKOV 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	09/25/1995
Decision Date	02/12/1996
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