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510(k) K833182

APLICARE ALCOHOL PREP PAD by Aplicare, Inc. — Product Code LKB

K833182 is an FDA 510(k) premarket notification submitted by Aplicare, Inc. for the device "APLICARE ALCOHOL PREP PAD". The FDA issued a decision of Substantially Equivalent on October 27, 1983. The device falls under product code LKB (Pad, Alcohol, Device Disinfectant), a Class U device. Aplicare, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1983
Date Received
September 19, 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 Aplicare, Inc.

  • K923299 — APLICARE ONE COMPUND BENZION TINCTURE SWABSTICK (January 18, 1994)
  • K895039 — STERILE SALINE - FOR SUCTION CATHETER LUBRICATION (October 3, 1989)
  • K873563 — APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY (November 23, 1987)
  • K861557 — APLICARE SKIN PROTECTANT PREP PAD (July 11, 1986)
  • K861558 — APLICARE SKIN PROTECTANT SWABSTICK (June 4, 1986)
  • K833185 — ACETONE ALCOHOL PREP PAD (October 31, 1983)
  • K833183 — APLICARE ONE ACETONE ALCOHOL SWABSTICK (October 31, 1983)
  • K833184 — APLICARE THREE ALCOHOL SWABSTICKS (October 27, 1983)

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)
  • K893958 — BAXTER ACETONE-ALCOHOL PREP PADS, STERILE (October 3, 1989)
  • K894791 — BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE (October 3, 1989)

FDA data resources