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510(k) K833141

ONE TIME ACETONE/ALCOHOL;SWAB STICKS by Acme United Corp. — Product Code LKB

K833141 is an FDA 510(k) premarket notification submitted by Acme United Corp. for the device "ONE TIME ACETONE/ALCOHOL;SWAB STICKS". The FDA issued a decision of Substantially Equivalent on October 31, 1983. The device falls under product code LKB (Pad, Alcohol, Device Disinfectant), a Class U device. Acme United Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1983
Date Received
September 14, 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 Acme United Corp.

  • K961323 — LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING (June 19, 1996)
  • K961452 — LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING (May 31, 1996)
  • K952565 — LYOFOAM EXTRA (November 14, 1995)
  • K895764 — MODIFIED LYOFOAM WOUND DRESSINGS (September 10, 1990)
  • K871740 — LYOSHEET SURGICAL SHEET FOR BURNS (June 9, 1987)
  • K864084 — LYOFOAM C ODOR-ABSORBING DRESSING (November 21, 1986)
  • K860085 — LYOFOAM WOUND DRESSINGS (June 27, 1986)
  • K860818 — ONE TIME ENTERAL FEEDING BAG (May 15, 1986)
  • K861015 — ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS (April 22, 1986)
  • K842186 — ACU-DERM TRANSPARENT WOUND DRESSING (August 24, 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