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510(k) K082238

NEOMED POLYURETHANE FEEDING TUBE by Neomed, Inc. — Product Code FPD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2008
Date Received
August 7, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Feeding
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Neomed, Inc.

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  • K152857 — NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure (December 17, 2015)
  • K143344 — NeoMed NeoConnect Enteral Syringes with ENFit Connector (April 9, 2015)
  • K122373 — NEOMED ORAL/ENTERAL SYRINGE (September 20, 2012)
  • K120182 — NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES (April 19, 2012)
  • K100288 — NEOMED ENTERAL ONLY EXTENSION SET (August 3, 2010)
  • K092908 — NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD (March 10, 2010)
  • K081515 — NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 (July 21, 2008)
  • K073596 — NEOMED SINGLE LUMEN UMBILICAL CATHETER (February 22, 2008)

Other clearances for product code FPD

  • K243361 — Nutrifit (December 19, 2024)
  • K180236 — VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) (January 18, 2019)
  • K131590 — INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE (October 23, 2013)
  • K120815 — INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE (March 6, 2013)
  • K121105 — NUTRISAFE 2 FEEDING TUBE (December 18, 2012)
  • K100163 — NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX (October 13, 2011)
  • K110853 — VR MEDICAL ENTERAL ORAL SYRINGE (May 13, 2011)
  • K100700 — MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES (December 13, 2010)
  • K101214 — GUARDIAN CONNECTION (July 23, 2010)
  • K100099 — ORAL/ENTERAL SYRINGES (June 14, 2010)