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510(k) K874867

CATR(TM)-H CARDIOTOMY HOLDER by Bentley Laboratories, Inc. — Product Code KPI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1988
Date Received
November 27, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Non-Implantable, For Incontinence
Device Class
Class II
Regulation Number
876.5320
Review Panel
GU
Submission Type

Other clearances by Bentley Laboratories, Inc.

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  • K903641 — QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q (November 9, 1990)
  • K894826 — UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF (February 28, 1990)
  • 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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