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510(k) K801968

HEMOCATH I KIDNEY DIALYSIS CATHETER by Medical Components, Inc. — Product Code LBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1980
Date Received
August 19, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Dialysis, Single Needle (Co-Axial Flow)
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

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Other clearances for product code LBW

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  • K860515 — DUAL LUMEN NEEDLE (PRODUCT CHANGE) (March 4, 1986)
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