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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 K011679
Device Name FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY
Applicant
Embryotech Laboratories, Inc.
19 Sedgemeadow Rd.
Wayland,  MA  01778
Applicant Contact ANN D MCGONIGLE
Correspondent
Embryotech Laboratories, Inc.
19 Sedgemeadow Rd.
Wayland,  MA  01778
Correspondent Contact ANN D MCGONIGLE
Regulation Number864.5220
Classification Product Code
POV  
Date Received05/30/2001
Decision Date 08/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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