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510(k) K811292

PARALLEL PLATE DIALYZER HOLDER by Extracorporeal Medical Specialities, Inc. — Product Code FKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1981
Date Received
May 11, 1981
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

Other clearances by Extracorporeal Medical Specialities, Inc.

  • K843955 — EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR (November 29, 1984)
  • K840262 — HANCOCK PERICARDIAL PATCH (May 30, 1984)
  • K840532 — HEMOPERFUSION SYSTEM TP-400 (May 30, 1984)
  • K840057 — EXP* 500 PARALLEL PLATE DIALYZER (February 4, 1984)
  • K840146 — EXP* 700 PARALLEL PLATE DIALYZER (February 4, 1984)
  • K831423 — THERAPEUTIC EXCHANGE SYSTEM (January 3, 1984)
  • K832547 — ULTRAFILTRATION CONTROLLER (January 3, 1984)
  • K833477 — INTERSEPT 40 MICRON FILTER (December 27, 1983)
  • K833476 — INTERSEPT 40 MICRON FILTER W/TUBING (December 27, 1983)
  • K831424 — THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 (October 14, 1983)

Other clearances for product code FKI

  • K843504 — AMER. BENTLEY HEMOFILTER HOLDER HFH-1 (October 18, 1984)
  • K802075 — HOLLOW FIBER DIALYZER HOLDER (September 16, 1980)