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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 K172514
Device Name Trak Plus Male Fertility Testing System
Applicant
Sandstone Diagnostics, Inc.
6111 Southfront Rd., Suite J
Livermore,  CA  94551
Applicant Contact Ulrich Schaff
Correspondent
Sandstone Diagnostics, Inc.
6111 Southfront Rd., Suite J
Livermore,  CA  94551
Correspondent Contact Ulrich Schaff
Regulation Number864.5220
Classification Product Code
POV  
Date Received08/21/2017
Decision Date 11/17/2017
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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