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510(k) K033270

NOVOSCI READY SYSTEM, MODEL RS-200 by Novosci Corp. — Product Code KFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2004
Date Received
October 10, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Device Class
Class II
Regulation Number
870.4360
Review Panel
CV
Submission Type

Other clearances by Novosci Corp.

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  • K033328 — NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT (January 16, 2004)

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