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510(k) K031949

TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 by Baylis Medical Co., Inc. — Product Code DXF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2003
Date Received
June 24, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Septostomy
Device Class
Class II
Regulation Number
870.5175
Review Panel
CV
Submission Type

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