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510(k) K003105

BIOSPHERE MEDICAL INFUSION CATHETER by Biosphere Medical — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2001
Date Received
October 4, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

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