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510(k) K813012

STERILE BASIN SETS by Medspec Corp. — Product Code LDQ

K813012 is an FDA 510(k) premarket notification submitted by Medspec Corp. for the device "STERILE BASIN SETS". The FDA issued a decision of Substantially Equivalent on November 6, 1981. Medspec Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1981
Date Received
October 27, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Medspec Corp.

  • K812707 — STERILE DISSECTOR SPONGES-X-RAY DETECT (November 2, 1981)
  • K812710 — STERILE LAPAROTOMY SPONGES-X-RAY DETECT (November 2, 1981)
  • K812711 — STERILE GAUZE PADS 12PLY (November 2, 1981)
  • K812709 — STERILE DENTAL ROLL (October 23, 1981)
  • K810071 — STERILE SILICONE TUBING (February 12, 1981)
  • K810069 — STERILE AIRWAY (February 2, 1981)
  • K802060 — STERILE TONSIL SPONGES (October 10, 1980)
  • K801069 — STERILE ISOLATION GOWN (May 20, 1980)
  • K801068 — STERILE ABDOMINAL PAD (May 20, 1980)
  • K800278 — MEDSPEC SAFETY PINS (May 2, 1980)

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