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510(k) K141753

AQUARIUS NASAL FEEDING TUBE by Degania Silicone , Ltd. — Product Code PIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2014
Date Received
June 30, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gastrointestinal Tubes With Enteral Specific Connectors
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

To facilitate enteral specific connections.

Other clearances by Degania Silicone , Ltd.

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  • K143378 — AQUARIUS Gastrostomy Replacement Tube (December 29, 2014)
  • K141631 — AQUARIUS EXTENSION FEEDING SET (July 28, 2014)
  • K132686 — AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE (May 12, 2014)
  • K131020 — TEMPERATURE SENSOR CATHETER (May 9, 2013)
  • K122030 — LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON (September 5, 2012)
  • K103371 — COUDE/ OR TIEMANN (March 11, 2011)
  • K070124 — GASTROSTOMY REPLACEMENT TUBE, MODEL 253 (May 23, 2007)
  • K063442 — ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR (March 26, 2007)

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