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510(k) K944669

FLEXIFLO QUANTUM ENTERAL PUMP by Abbott Mfg., Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1995
Date Received
September 13, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Abbott Mfg., Inc.

  • K981457 — ALBP (May 27, 1998)
  • K981232 — CA (May 18, 1998)
  • K981231 — CO2 (May 12, 1998)
  • K965230 — ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP (July 3, 1997)
  • K971293 — LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE (June 27, 1997)
  • K953656 — ABBOTT IMX PROLACTIN(MODIFICATION) (October 3, 1995)
  • K953657 — ABBOTT AXSYM PROLACTIN(MODIFICATION) (September 25, 1995)
  • K943691 — IMX FOLATE (March 23, 1995)
  • K943733 — FLEXIFLO SIX ENTERAL NUTRITION PUMP (December 12, 1994)
  • K941214 — LIFESHIELD EXTENSION SET (October 3, 1994)

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