FDA 510(k) Application Details - K032161

Device Classification Name	Paper, Obstetric Ph   More FDA Info for this Device
510(K) Number	K032161
Device Name	Paper, Obstetric Ph
Applicant	FEMTEK,LLC. 11605 HITCHING POST LN. ROCKVILLE, MD 20852 US Other 510(k) Applications for this Company
Contact	JOEL S FADEN Other 510(k) Applications for this Contact
Regulation Number	862.1550   More FDA Info for this Regulation Number
Classification Product Code	LNW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/15/2003
Decision Date	09/30/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review