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510(k) K042016

DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER by Datascope Corp. — Product Code MSD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2004
Date Received
July 27, 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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