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510(k) K833141

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

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

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  • K871740 — LYOSHEET SURGICAL SHEET FOR BURNS (June 9, 1987)
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  • 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)

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  • 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)