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510(k) K894939

PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY by North American Sterilization & Packaging Co. — Product Code FPD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1989
Date Received
August 3, 1989
Clearance Type
Traditional
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 North American Sterilization & Packaging Co.

  • K964231 — NASP HYDROCOLLOID DRESSING (REGULAR OR THIN) (March 10, 1997)
  • K963753 — NASP TRANSPARENT DRESSING (November 29, 1996)
  • K962352 — HYDROGEL SKIN DRESSING (August 2, 1996)
  • K925593 — NORTEC STERILE WATER FOR DEVICE IRRIGATION (December 3, 1993)
  • K925588 — NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI (December 3, 1993)
  • K925161 — NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO (July 21, 1993)
  • K911865 — NORTEC CONNECTING TUBE SET (November 1, 1991)
  • K911784 — NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY (September 23, 1991)
  • K910691 — NORTEC URETERAL STENT (August 15, 1991)
  • K903162 — FLEXIBLE ENDOSCOPIC ELECTRODES (December 18, 1990)

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)