The following data is part of a premarket notification filed by Genosis Ltd. with the FDA for Fertell Male Fertility Test.
Device ID | K041039 |
510k Number | K041039 |
Device Name: | FERTELL MALE FERTILITY TEST |
Classification | Semen Analysis Device |
Applicant | GENOSIS LTD. 1111 PENNSYLVANIA AVE. N.W. Washington, DC 20004 |
Contact | Sharon A Segal |
Correspondent | Sharon A Segal GENOSIS LTD. 1111 PENNSYLVANIA AVE. N.W. Washington, DC 20004 |
Product Code | POV |
CFR Regulation Number | 864.5220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-04-22 |
Decision Date | 2004-07-20 |
Summary: | summary |