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510(k) K781748

IRRIGATION TRAY by Intermed, Inc. — Product Code EYN

K781748 is an FDA 510(k) premarket notification submitted by Intermed, Inc. for the device "IRRIGATION TRAY". The FDA issued a decision of Substantially Equivalent on December 12, 1978. The device falls under product code EYN (Tray, Irrigation, Sterile), a Class II device regulated under 21 CFR 876.5980. Intermed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1978
Date Received
October 17, 1978
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 Intermed, Inc.

  • K900857 — NON STERILE PARENTERAL SUPPLY KIT (May 22, 1990)
  • K842166 — INTERMED, INS STERILE WATER/SALINE (February 12, 1985)
  • K833126 — DRESSING CHANGE TRAYS (January 27, 1984)
  • K833574 — PERCUTANEOUS SHEATH INTRODUCER TRAYS (January 11, 1984)
  • K833573 — CENTRAL VEIN CATH. TRAY CC-20-1420 (January 11, 1984)
  • K833139 — ACUTE HEMODIALYSIS TRAYS (December 22, 1983)
  • K833059 — SUCTION CATHETER TRAYS (December 12, 1983)
  • K821269 — TRACHEOSTOMY CARE TRAYS (May 27, 1982)
  • K791427 — CATHETERIZATION TRAYS FOLEY AND URETHRAL (September 7, 1979)
  • K791426 — PERITONEAL PAC (August 28, 1979)

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)
  • K792082 — GAVAGE FEEDING SET (November 13, 1979)

FDA data resources