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510(k) K113487

HEMO-CATH 10F, HEMO-CATH 12.5F by Medical Components, Inc. — Product Code MSD

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
March 9, 2012
Date Received
November 23, 2011
Clearance Type
Special
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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  • K122423 — VASU-PICC (December 12, 2012)
  • K121848 — SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT (September 21, 2012)

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