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510(k) K896898

BOWEN ELECTRODE SKIN PREPATORY CLEANSER by Bowen & Company, Inc. — Product Code LKB

K896898 is an FDA 510(k) premarket notification submitted by Bowen & Company, Inc. for the device "BOWEN ELECTRODE SKIN PREPATORY CLEANSER". The FDA issued a decision of Substantially Equivalent on April 4, 1990. The device falls under product code LKB (Pad, Alcohol, Device Disinfectant), a Class U device. Bowen & Company, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1990
Date Received
December 8, 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 by Bowen & Company, Inc.

  • K896538 — DISPOSABLE 45 DEGREE SHAVER (December 6, 1989)
  • K873766 — STERNAL POWER AWL (November 14, 1988)
  • K872098 — CREMEEN ALVEOLAR BONE CALIPER (July 31, 1987)
  • K871325 — BOWEN REUSEABLE/DISPOSABLE ELECTRODE (June 8, 1987)
  • K870881 — LOOSE BODY GRASPERS (March 23, 1987)
  • K870882 — 45 DEGREE SHAVER (March 23, 1987)
  • K863148 — BOWEN KNOT PASSER (September 5, 1986)
  • K863150 — BOWEN CANNULA (September 5, 1986)
  • K863149 — BOWEN PROBE (September 5, 1986)
  • K863146 — BOWEN SUTURE PASSER (September 5, 1986)

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)
  • 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