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510(k) K982340

EXTRACORPOREAL BLOOD CIRCUIT by Haidylena Medical Egypt — Product Code FJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1999
Date Received
July 6, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Haidylena Medical Egypt

  • K982337 — CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER (December 29, 1998)

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