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510(k) K001958

KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL 12 F DUO-FLOW AND 14F DUO-FLOW 400 XL CATH by Keystone Medical — Product Code MPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2000
Date Received
June 27, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Keystone Medical

  • K011860 — KEYST0NE MEDICAL PICC CATHETER (June 27, 2001)

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