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510(k) K910735

HEXIDIS ALCOHOL SWAB by Specialites Septodont — Product Code LKB

K910735 is an FDA 510(k) premarket notification submitted by Specialites Septodont for the device "HEXIDIS ALCOHOL SWAB". The FDA issued a decision of Substantially Equivalent on April 2, 1991. The device falls under product code LKB (Pad, Alcohol, Device Disinfectant), a Class U device. Specialites Septodont has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1991
Date Received
February 21, 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 by Specialites Septodont

  • K012427 — PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT (October 9, 2001)
  • K010415 — ISODAN (July 23, 2001)
  • K982773 — QUICKSET LIQUID AND POWDER (November 3, 1998)
  • K982671 — SECURALLOY (October 19, 1998)
  • K980633 — ENDOSOLV E (May 1, 1998)
  • K920692 — SEPTOCALCINE ULTRA (April 21, 1992)
  • K915467 — CIMPAT S DENTAL CEMENT (February 3, 1992)
  • K915466 — SEPTOPACK TEMPORARY FILLING (February 3, 1992)
  • K913573 — SAFETY PLUS DENTAL INJECTION NEEDLE (November 7, 1991)
  • K913572 — AUTOPACK NON-EUGENOL PERIODONTAL DRESSING (October 9, 1991)

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

FDA data resources