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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Quality Control, Semen Analysis
510(k) Number K041240
Device Name SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED
Applicant
FERTILITY SOLUTIONS, INC.
13000 SHAKER BLVD.
CLEVELAND,  OH  44120
Applicant Contact SUSAN A ROTHMANN, PH.D., HCLD
Correspondent
FERTILITY SOLUTIONS, INC.
13000 SHAKER BLVD.
CLEVELAND,  OH  44120
Correspondent Contact SUSAN A ROTHMANN, PH.D., HCLD
Regulation Number864.8625
Classification Product Code
NRF  
Date Received05/11/2004
Decision Date 06/02/2004
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
Predetermined Change
Control Plan Authorized		 No
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