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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 Jun 28, 1995. Palco Laboratories, Inc. has 8 other 510(k) clearances on record.

Clearance details

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

Other clearances by Palco Laboratories, Inc.

  • K943842 — PULSE OXIMETER MODEL 305 (Mar 24, 1995)
  • K920066 — PALCO LABS MODEL 340 PULSE OXIMETER (Mar 16, 1993)
  • K913694 — PALCO LABS LOADMATIC (Dec 17, 1991)
  • K911191 — PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR (Jun 10, 1991)
  • K904988 — PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR (Mar 18, 1991)
  • K872233 — INJECT-EASE (Sep 4, 1987)
  • K842547 — WET-STOP (Oct 19, 1984)
  • K833344 — AUTO-LANCET (Nov 7, 1983)

Other clearances for product code LDQ

  • K993797 — EC-7701 FLUID WARMING CABINET (Jan 20, 2000)
  • K992258 — HOT SHOT FLUID WARMER IV FLUIDS (Jan 12, 2000)
  • K981032 — PIV SYSTEM (Sep 2, 1998)
  • K973747 — CONTROLLED TEMPERATURE CABINET SYSTEM (May 7, 1998)
  • K955661 — ACU-HALT (Dec 30, 1996)
  • K955776 — ACU-LAB (Jun 5, 1996)
  • K945374 — ACU-HALT (Aug 9, 1995)
  • K944961 — PERSONAL ALARM SYSTEM (PAS) (Aug 7, 1995)
  • K930884 — MEDICAL PROCEDURE TRAY, MODIFICATION (Mar 21, 1995)
  • K934703 — MEDICOOL PROTECTALL (Jan 26, 1994)

FDA data resources

Source: FDA 510(k) database entry for K942810. Report a data issue: hello@regdatalab.com.