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510(k) K944882

IRRIGATION TRAY by Clinical Resources, Inc. — Product Code EYN

K944882 is an FDA 510(k) premarket notification submitted by Clinical Resources, Inc. for the device "IRRIGATION TRAY". The FDA issued a decision of Substantially Equivalent on January 12, 1995. The device falls under product code EYN (Tray, Irrigation, Sterile), a Class II device regulated under 21 CFR 876.5980. Clinical Resources, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1995
Date Received
October 3, 1994
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 Clinical Resources, Inc.

  • K941470 — TRACHEOSTOMY CARE KIT (February 14, 1995)
  • K944881 — SKIN SCRUB TRAY (December 27, 1994)
  • K945019 — FLUFF GAUXZE ROLL (December 23, 1994)
  • K945021 — FLUFF GAUZE SPONGE (December 23, 1994)
  • K945020 — FLUFF GAUZE SPONGE (December 23, 1994)
  • K944879 — GAUZE SPONGES (December 23, 1994)
  • K944880 — BODILY FLUID DISPOSAL KIT (December 15, 1994)
  • K941467 — WOUND DRESSING KIT (May 12, 1994)
  • K941471 — CENTRAL LINE DRESSING CHANGE TRAY (May 12, 1994)
  • K941469 — IV START KIT (May 12, 1994)

Other clearances for product code EYN

  • K923938 — IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER (June 17, 1993)
  • K923941 — IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE (June 17, 1993)
  • K923939 — IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER (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)
  • K792082 — GAVAGE FEEDING SET (November 13, 1979)
  • K791020 — FLUID ADMINISTRATION SET FA-3160 (June 27, 1979)

FDA data resources