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510(k) K895674

MEDICOOL, CONTAINER FOR STORING INSULIN by Medicool, Inc. — Product Code LDQ

K895674 is an FDA 510(k) premarket notification submitted by Medicool, Inc. for the device "MEDICOOL, CONTAINER FOR STORING INSULIN". The FDA issued a decision of Substantially Equivalent on January 11, 1990. Medicool, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1990
Date Received
September 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Medicool, Inc.

  • K073555 — INSULIN PROTECTOR (July 11, 2008)

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