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510(k) K902410

MEDICAL PROCEDURE TRAY by Sorex Medical — Product Code LDQ

K902410 is an FDA 510(k) premarket notification submitted by Sorex Medical for the device "MEDICAL PROCEDURE TRAY". The FDA issued a decision of Substantially Equivalent (kit, denovo) on November 20, 1990. Sorex Medical has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
November 20, 1990
Date Received
May 31, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Sorex Medical

  • K923843 — FOGLESS (March 25, 1994)
  • K913036 — PLUME MASTER (September 6, 1991)
  • K911070 — PICC-FIX (July 5, 1991)
  • K911150 — SOREX SAFE-AIR (June 28, 1991)
  • K910315 — PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K (April 5, 1991)
  • K905572 — EDLICH WOUND MANAGEMENT TRAY (March 12, 1991)
  • K903740 — TRACH-EZE (December 6, 1990)
  • K885136 — GRAFT GUARD (February 6, 1989)

Other clearances for product code LDQ

  • K993797 — EC-7701 FLUID WARMING CABINET (January 20, 2000)
  • K992258 — HOT SHOT FLUID WARMER IV FLUIDS (January 12, 2000)
  • K981032 — PIV SYSTEM (September 2, 1998)
  • K973747 — CONTROLLED TEMPERATURE CABINET SYSTEM (May 7, 1998)
  • K955661 — ACU-HALT (December 30, 1996)
  • K955776 — ACU-LAB (June 5, 1996)
  • K945374 — ACU-HALT (August 9, 1995)
  • K944961 — PERSONAL ALARM SYSTEM (PAS) (August 7, 1995)
  • K942810 — PALCO LABS COLD POUCH (June 28, 1995)
  • K930884 — MEDICAL PROCEDURE TRAY, MODIFICATION (March 21, 1995)

FDA data resources