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510(k) K831029

HEMOPERFUSION SYSTEM TP-400 by Extracorporeal Medical Specialities, Inc. — Product Code FLD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1983
Date Received
March 30, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Hemoperfusion, Sorbent
Device Class
Class II
Regulation Number
876.5870
Review Panel
GU
Submission Type

Other clearances by Extracorporeal Medical Specialities, Inc.

  • K843955 — EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR (November 29, 1984)
  • K840532 — HEMOPERFUSION SYSTEM TP-400 (May 30, 1984)
  • K840262 — HANCOCK PERICARDIAL PATCH (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)

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  • K971015 — AHCS HEMOPERFUSION SYSTEM (October 22, 1997)
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  • K885017 — HEMOSORBA CH-500, CH-350 AND CH-180 (March 17, 1989)
  • K873643 — GAMBRO ADSORBA 150C (December 29, 1987)
  • K840532 — HEMOPERFUSION SYSTEM TP-400 (May 30, 1984)