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510(k) K801082

GAMBRO HEMOFREEZE-BAG by Gambro, Inc. — Product Code KSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1980
Date Received
May 7, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Empty, For Collection & Processing Of Blood & Blood Components
Device Class
Class II
Regulation Number
864.9100
Review Panel
HE
Submission Type

Other clearances by Gambro, Inc.

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  • K070643 — PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35 (November 2, 2007)
  • K032431 — PRISMA M60/M100 SETS (September 15, 2003)
  • K896758 — GAMBRO BICARBONATE MONITOR BCM 10-3 (September 28, 1990)
  • K896757 — GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS (August 30, 1990)
  • K902481 — GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER (July 27, 1990)
  • K900918 — GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER (July 16, 1990)
  • K892523 — GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY (May 11, 1989)
  • K890112 — ENGSTROM ELIZA + CO2 ANALYZER (March 15, 1989)

Other clearances for product code KSR

  • K032827 — KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 (December 8, 2003)
  • K020753 — DEROYAL SURGICAL, UMBILICUP (June 13, 2002)
  • K810500 — BLOOD FREEZING BAG (September 23, 1981)
  • K810897 — ALPHA PLASTIC PLASMA BOTTLE (September 23, 1981)
  • K811523 — PLASMA FLEX (September 9, 1981)
  • K811449 — HAEMONETICS 1000ML COMPONENT BAG (July 1, 1981)
  • K810711 — HAEMONETICS 600 ML. COMPONENT BAG (May 8, 1981)
  • K810313 — HAEMONETICS 1400 ML THERAPEUTIC BAG (March 31, 1981)
  • K801219 — PLASMAPOOLER (October 31, 1980)
  • K792395 — PHARMAFLEX CRYOGENIC BAG (February 26, 1980)