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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Centrifuge, Hematocrit
510(k) Number K955795
Device Name MULTI-CENTRIFUGE
Applicant
Novonx, Inc.
2257 S. 11000 E.
Suite 1a
Salt Lake City,  UT  84106
Applicant Contact GLEN S PUTNAM
Correspondent
Novonx, Inc.
2257 S. 11000 E.
Suite 1a
Salt Lake City,  UT  84106
Correspondent Contact GLEN S PUTNAM
Regulation Number864.6400
Classification Product Code
GKG  
Date Received12/22/1995
Decision Date 03/29/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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