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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinner, Slide, Automated
510(k) Number K854121
Device Name MICRO-MAT SYSTEM
Applicant
Prevo Micro-Mat System
P.O. Box 902
Highland,  NY  12528
Applicant Contact ROBERT K MCEWEN
Correspondent
Prevo Micro-Mat System
P.O. Box 902
Highland,  NY  12528
Correspondent Contact ROBERT K MCEWEN
Regulation Number864.5850
Classification Product Code
GKJ  
Date Received10/09/1985
Decision Date 10/31/1985
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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