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510(k) K843504

AMER. BENTLEY HEMOFILTER HOLDER HFH-1 by American Bentley — Product Code FKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1984
Date Received
September 6, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Dialyzer Holder
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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Other clearances for product code FKI

  • K811292 — PARALLEL PLATE DIALYZER HOLDER (June 2, 1981)
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