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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Hematocrit, Automated
510(k) Number K864039
Device Name MICROHEMATOCRIT CENTRIFUGE
Applicant
Plaza Medical, Inc.
9780 E. Girard
Denver,  CO  80231
Applicant Contact RICE, JR
Correspondent
Plaza Medical, Inc.
9780 E. Girard
Denver,  CO  80231
Correspondent Contact RICE, JR
Regulation Number864.5600
Classification Product Code
GKF  
Date Received10/16/1986
Decision Date 10/29/1986
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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