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510(k) K934703

MEDICOOL PROTECTALL by Avc Regulatory Compliance/Technical Services — Product Code LDQ

K934703 is an FDA 510(k) premarket notification submitted by Avc Regulatory Compliance/Technical Services for the device "MEDICOOL PROTECTALL". The FDA issued a decision of Substantially Equivalent on January 26, 1994.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1994
Date Received
September 30, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances for product code LDQ

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  • 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