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510(k) K070124

GASTROSTOMY REPLACEMENT TUBE, MODEL 253 by Degania Silicone , Ltd. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2007
Date Received
January 16, 2007
Clearance Type
Traditional
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

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  • K141753 — AQUARIUS NASAL FEEDING TUBE (October 16, 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)
  • K063442 — ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR (March 26, 2007)

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