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510(k) K021481

BRESAGEN CATHETER, MODEL CS-3000 by Bresagen, Inc. — Product Code HCA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2002
Date Received
May 8, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ventricular
Device Class
Class II
Regulation Number
882.4100
Review Panel
NE
Submission Type

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