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510(k) K942810

PALCO LABS COLD POUCH by Palco Laboratories, Inc. — Product Code LDQ

K942810 is an FDA 510(k) premarket notification submitted by Palco Laboratories, Inc. for the device "PALCO LABS COLD POUCH". The FDA issued a decision of Substantially Equivalent on June 28, 1995. Palco Laboratories, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1995
Date Received
June 15, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Palco Laboratories, Inc.

  • K943842 — PULSE OXIMETER MODEL 305 (March 24, 1995)
  • K920066 — PALCO LABS MODEL 340 PULSE OXIMETER (March 16, 1993)
  • K913694 — PALCO LABS LOADMATIC (December 17, 1991)
  • K911191 — PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR (June 10, 1991)
  • K904988 — PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR (March 18, 1991)
  • K872233 — INJECT-EASE (September 4, 1987)
  • K842547 — WET-STOP (October 19, 1984)
  • K833344 — AUTO-LANCET (November 7, 1983)

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)
  • K930884 — MEDICAL PROCEDURE TRAY, MODIFICATION (March 21, 1995)
  • K934703 — MEDICOOL PROTECTALL (January 26, 1994)

FDA data resources