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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 K894949
FOIA Releasable 510(k) K894949
Device Name SQA
Applicant
United Medical Systems, Inc.
Mackler And Gibbs, P.C.
1120 Vermont Ave., Suite 600
Washington,  DC  20005
Applicant Contact BRUCE F MACKLER
Correspondent
United Medical Systems, Inc.
Mackler And Gibbs, P.C.
1120 Vermont Ave., Suite 600
Washington,  DC  20005
Correspondent Contact BRUCE F MACKLER
Regulation Number864.5220
Classification Product Code
POV  
Date Received08/03/1989
Decision Date 12/29/1989
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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