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510(k) K912731

STERI-SWAB by Westlock Investments (Usa), Inc. — Product Code LKB

K912731 is an FDA 510(k) premarket notification submitted by Westlock Investments (Usa), Inc. for the device "STERI-SWAB". The FDA issued a decision of Substantially Equivalent on October 2, 1991. The device falls under product code LKB (Pad, Alcohol, Device Disinfectant), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1991
Date Received
June 20, 1991
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)
  • 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)
  • K892193 — QUICKPAD (ALCOHOL SWABS) (August 4, 1989)

FDA data resources