FDA 510(k) Application Details - K041039

Device Classification Name	More FDA Info for this Device
510(K) Number	K041039
Device Name	FERTELL MALE FERTILITY TEST
Applicant	GENOSIS LTD. 1111 PENNSYLVANIA AVE. N.W. WASHINGTON, DC 20004 US Other 510(k) Applications for this Company
Contact	SHARON A SEGAL Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2004
Decision Date	07/20/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review