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510(k) K892193

QUICKPAD (ALCOHOL SWABS) by Holtsch Co., Inc. — Product Code LKB

K892193 is an FDA 510(k) premarket notification submitted by Holtsch Co., Inc. for the device "QUICKPAD (ALCOHOL SWABS)". The FDA issued a decision of Substantially Equivalent on August 4, 1989. The device falls under product code LKB (Pad, Alcohol, Device Disinfectant), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1989
Date Received
April 5, 1989
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 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