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510(k) K913692

VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) by Bentley Laboratories, Inc. — Product Code DTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1991
Date Received
August 19, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reservoir, Blood, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4400
Review Panel
CV
Submission Type

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  • K894826 — UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF (February 28, 1990)
  • K874867 — CATR(TM)-H CARDIOTOMY HOLDER (February 2, 1988)
  • K874841 — INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER (February 2, 1988)
  • K874618 — BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER (January 19, 1988)
  • K823359 — OXYGEN CONSUMPTION MONITOR #OCM-0100 (January 5, 1983)
  • K823273 — BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN. (January 5, 1983)
  • K823456 — OXYGENATORS #BOS-10, 105, 5S (December 30, 1982)

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