Home / 510(k) Clearances / K760815

510(k) K760815

FITTING/DIALYZER by Cobe Laboratories, Inc. — Product Code FTG

K760815 is an FDA 510(k) premarket notification submitted by Cobe Laboratories, Inc. for the device "FITTING/DIALYZER". The FDA issued a decision of Substantially Equivalent on November 19, 1976. The device falls under product code FTG (Illuminator, Remote), a Class II device regulated under 21 CFR 878.4580. Cobe Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1976
Date Received
October 12, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Illuminator, Remote
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Cobe Laboratories, Inc.

  • K923272 — COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR (May 11, 1993)
  • K900105 — COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC (March 22, 1991)
  • K905793 — COBE CENTRY 2 BICART OPTION KIT (February 12, 1991)
  • K905388 — COBE CENTRYSYSTEM 3 BICART OPTION KIT (February 11, 1991)
  • K904336 — NEW COBE SATURATION/HEMATOCRIT MONITOR (December 27, 1990)
  • K902437 — COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER (December 17, 1990)
  • K902631 — COBE ICU CONVERSION KIT (December 17, 1990)
  • K904566 — NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER (December 12, 1990)
  • K902758 — COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC (August 23, 1990)
  • K902759 — COBE CLOSED WOUND DRAINAGE KIT (July 18, 1990)

Other clearances for product code FTG

  • K801065 — NIKKISO PARALLEL FLOW DIALYZERS (August 7, 1980)

FDA data resources