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510(k) K894791

BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE by Span-America Medical Systems, Inc. — Product Code LKB

K894791 is an FDA 510(k) premarket notification submitted by Span-America Medical Systems, Inc. for the device "BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE". The FDA issued a decision of Substantially Equivalent on October 3, 1989. The device falls under product code LKB (Pad, Alcohol, Device Disinfectant), a Class U device. Span-America Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1989
Date Received
July 28, 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 Span-America Medical Systems, Inc.

  • K972486 — PRESSUREGUARD IV (February 20, 1998)
  • K973169 — PRESSURE GUARD SITE SELECT (A) (February 20, 1998)
  • K960188 — PRESSUREGUARD: SELECTCARE (October 2, 1996)
  • K961502 — LUBRICATING JELLY, LOW VISCOSITY (July 18, 1996)
  • K961159 — POWERED LOW AIR LOSS MATTRESS SYSTEM (June 14, 1996)
  • K960620 — PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM (April 25, 1996)
  • K960189 — GEL-T CUSHION (February 7, 1996)
  • K954766 — PRESSURE GUARD ALTERNATING PRESSURE MATTRESS (January 11, 1996)
  • K953503 — PRESSUREGUARD IV (October 24, 1995)
  • K954117 — CUSTOMCARE SEATING SYSTEM (October 13, 1995)

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

FDA data resources