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510(k) K182443

Pristine Hemodialysis Catheter by Pristine Access Technologies , Ltd. — Product Code MSD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2019
Date Received
September 7, 2018
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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