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510(k) K792082

GAVAGE FEEDING SET by Medical Devices, Inc. — Product Code EYN

K792082 is an FDA 510(k) premarket notification submitted by Medical Devices, Inc. for the device "GAVAGE FEEDING SET". The FDA issued a decision of Substantially Equivalent on November 13, 1979. The device falls under product code EYN (Tray, Irrigation, Sterile), a Class II device regulated under 21 CFR 876.5980. Medical Devices, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1979
Date Received
October 16, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Irrigation, Sterile
Device Class
Class II
Regulation Number
876.5980
Review Panel
SU
Submission Type

Other clearances by Medical Devices, Inc.

  • K002280 — PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 (February 5, 2001)
  • K930084 — MICRO-ARTHROSCOPE (September 1, 1995)
  • K940012 — SMARTBRACE ELECTRODE (December 5, 1994)
  • K943126 — ELECTROFLEX (December 5, 1994)
  • K935132 — HOME MICROCURRENT HMC (March 14, 1994)
  • K934619 — FLEXMATE (February 23, 1994)
  • K924897 — XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300 (July 6, 1993)
  • K930053 — VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10 (May 17, 1993)
  • K923914 — IF-II (TM), MODEL 7200 (November 6, 1992)
  • K920071 — MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15 (July 21, 1992)

Other clearances for product code EYN

  • K944882 — IRRIGATION TRAY (January 12, 1995)
  • K923938 — IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER (June 17, 1993)
  • K923939 — IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER (June 17, 1993)
  • K923941 — IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE (June 17, 1993)
  • K923940 — IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE (June 17, 1993)
  • K900148 — KIT PAK IRRIGATION TRAY (April 23, 1990)
  • K900737 — PISTON IRRIGATION TRAY (April 19, 1990)
  • K900736 — BULB IRRIGATION TRAY (April 17, 1990)
  • K801783 — CATHETER IRRIGATION TRAYS, #3300, 3310 & (August 13, 1980)
  • K791020 — FLUID ADMINISTRATION SET FA-3160 (June 27, 1979)

FDA data resources