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510(k) K923941

IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE by American Healthcare Corp. — Product Code EYN

K923941 is an FDA 510(k) premarket notification submitted by American Healthcare Corp. for the device "IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE". The FDA issued a decision of Substantially Equivalent (kit, denovo) on June 17, 1993. The device falls under product code EYN (Tray, Irrigation, Sterile), a Class II device regulated under 21 CFR 876.5980. American Healthcare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
June 17, 1993
Date Received
August 5, 1992
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 American Healthcare Corp.

  • K043512 — EASYGLUCO IGM-0002 G2 (April 8, 2005)
  • K043543 — BLOOD GLUCOSE MONITORING SYSTEM (April 8, 2005)
  • K031501 — EASYGLUCO, MODEL IGM0002 (October 16, 2003)
  • K924192 — I.V. START KIT (AHC-50-54954 (August 27, 1993)
  • K923940 — IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE (June 17, 1993)
  • K923939 — IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER (June 17, 1993)
  • K923938 — IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER (June 17, 1993)
  • K924193 — TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685) (June 16, 1993)
  • K924191 — TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL (April 2, 1993)
  • K924194 — TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686) (January 6, 1993)

Other clearances for product code EYN

  • K944882 — IRRIGATION TRAY (January 12, 1995)
  • K923938 — IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER (June 17, 1993)
  • K923940 — IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE (June 17, 1993)
  • K923939 — IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER (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)
  • K792082 — GAVAGE FEEDING SET (November 13, 1979)
  • K791020 — FLUID ADMINISTRATION SET FA-3160 (June 27, 1979)

FDA data resources