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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name semen analysis device
510(k) Number K161493
Device Name YO Home Sperm Test
Applicant
MEDICAL ELECTRONIC SYSTEMS, LTD
ALON HATAVOR ST.20
ZONE 6
CAESAREA IND. PARK,  IL 38900
Applicant Contact MARCIA DEUTSCH
Correspondent
AMMIRATI REGULATORY CONSULTING
575 SHIRLYNN COURT
LOS ALTOS,  CA  94022
Correspondent Contact Erika Ammirati
Regulation Number864.5220
Classification Product Code
POV  
Date Received06/01/2016
Decision Date 11/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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