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510(k) K955795

MULTI-CENTRIFUGE by Novonx, Inc. — Product Code GKG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1996
Date Received
December 22, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Centrifuge, Hematocrit
Device Class
Class II
Regulation Number
864.6400
Review Panel
HE
Submission Type

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