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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 K881765
FOIA Releasable 510(k) K881765
Device Name CTS-3060 AUTOMATED SEMEN ANALYZER
Applicant
Motion Analysis Corp.
3650 N. Laughlin Rd.
Santa Rosa,  CA  95403
Applicant Contact HAND, PHD
Correspondent
Motion Analysis Corp.
3650 N. Laughlin Rd.
Santa Rosa,  CA  95403
Correspondent Contact HAND, PHD
Regulation Number864.5220
Classification Product Code
POV  
Date Received04/25/1988
Decision Date 02/15/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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