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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
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