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510(k) K833936

ACETONE ALCOHOL SWABS by Concord Laboratories, Inc. — Product Code LKB

K833936 is an FDA 510(k) premarket notification submitted by Concord Laboratories, Inc. for the device "ACETONE ALCOHOL SWABS". The FDA issued a decision of Substantially Equivalent on January 30, 1984. The device falls under product code LKB (Pad, Alcohol, Device Disinfectant), a Class U device. Concord Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1984
Date Received
November 15, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pad, Alcohol, Device Disinfectant
Device Class
Class U
Regulation Number
Review Panel
HO
Submission Type

Other clearances by Concord Laboratories, Inc.

  • K883840 — DRI-VENT ARTERIAL BLOOD SAMPLING KIT (May 16, 1989)
  • K871825 — MECONIUM SUCTION CATHETER (June 29, 1987)
  • K864535 — TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110 (January 6, 1987)
  • K862039 — CONCORD CARE TRAY (July 3, 1986)
  • K854601 — SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH (January 10, 1986)
  • K854327 — SUBCUTANEOUS TUNNELING NEEDLES & HANDLES (November 13, 1985)
  • K851134 — REGIONAL ANESTHESIA TRAYS (July 15, 1985)
  • K842095 — EPIDURAL TRAYS (July 3, 1984)
  • K841486 — ARTERIAL BLOOD SAMPLING KITS (May 23, 1984)
  • K840987 — VAPORIZED HEPARIN (April 5, 1984)

Other clearances for product code LKB

  • K132380 — PREVANTICS DEVICE SWAB (August 27, 2014)
  • K121655 — BD ALCOHOL SWAB (March 20, 2013)
  • K112791 — SITESCRUB IPA DEVICE (February 24, 2012)
  • K912161 — I.V. STARR KIT (October 8, 1991)
  • K912731 — STERI-SWAB (October 2, 1991)
  • K910735 — HEXIDIS ALCOHOL SWAB (April 2, 1991)
  • K896898 — BOWEN ELECTRODE SKIN PREPATORY CLEANSER (April 4, 1990)
  • K896835 — ALCOHOL PREP AND POVIDONE-IODINE PREP (January 11, 1990)
  • K894791 — BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE (October 3, 1989)
  • K893958 — BAXTER ACETONE-ALCOHOL PREP PADS, STERILE (October 3, 1989)

FDA data resources