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510(k) K991908

IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS by Idemsa — Product Code FJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2000
Date Received
June 7, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Capillary, Hollow Fiber
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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  • K991512 — ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X (July 29, 1999)
  • K990159 — DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 (April 19, 1999)