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510(k) K885055

INSU COOL by Dynex Trading Co. — Product Code LDQ

K885055 is an FDA 510(k) premarket notification submitted by Dynex Trading Co. for the device "INSU COOL". The FDA issued a decision of Substantially Equivalent on April 26, 1989. Dynex Trading Co. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1989
Date Received
December 7, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Dynex Trading Co.

  • K882731 — TAB PAK (December 14, 1988)

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