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510(k) K080340

COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG by Novartis Nutrition Corp. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2008
Date Received
February 8, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Novartis Nutrition Corp.

  • K071191 — NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT (July 23, 2007)
  • K001916 — COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX (February 16, 2001)
  • K991668 — COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12) (July 26, 1999)
  • K981323 — COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE (October 9, 1998)

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