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510(k) K132380

PREVANTICS DEVICE SWAB by Professional Disposables International, Inc. — Product Code LKB

K132380 is an FDA 510(k) premarket notification submitted by Professional Disposables International, Inc. for the device "PREVANTICS DEVICE SWAB". The FDA issued a decision of Substantially Equivalent on August 27, 2014. The device falls under product code LKB (Pad, Alcohol, Device Disinfectant), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2014
Date Received
July 31, 2013
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

  • 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)
  • K892193 — QUICKPAD (ALCOHOL SWABS) (August 4, 1989)

FDA data resources