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510(k) K040666

STEP-TIP CHRONIC HEMODIALYSIS CATHETER by Arrow International, Inc. — Product Code MSD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2004
Date Received
March 15, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Hemodialysis, Implanted
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

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