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510(k) K113689

DUKAL LUBRICATING JELLY by Dukal Corporation — Product Code KMJ

K113689 is an FDA 510(k) premarket notification submitted by Dukal Corporation for the device "DUKAL LUBRICATING JELLY". The FDA issued a decision of Substantially Equivalent on May 4, 2012. The device falls under product code KMJ (Lubricant, Patient), a Class I device regulated under 21 CFR 880.6375. Dukal Corporation has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2012
Date Received
December 15, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lubricant, Patient
Device Class
Class I
Regulation Number
880.6375
Review Panel
HO
Submission Type

Other clearances by Dukal Corporation

  • K212464 — Dukal Corporation AAMI Level 4 Open-Back Protective Gown (March 30, 2022)
  • K210321 — Dukal Corporation Level 1 Pediatric Face Mask (March 29, 2022)
  • K203237 — Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgic (March 18, 2022)
  • K201732 — Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation L (February 16, 2021)
  • K201421 — Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level (February 5, 2021)
  • K070692 — DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK (May 30, 2007)

Other clearances for product code KMJ

  • K142473 — Lubricating Jelly (April 13, 2015)
  • K141028 — COLONGLIDE LUBRICANT (July 24, 2014)
  • K131617 — COLONGLIDE(R) LUBRICANT (October 3, 2013)
  • K121390 — LUBE JELLY SURINGE (August 10, 2012)
  • K112110 — STERILE LUBRICATING JELLY (April 10, 2012)
  • K103718 — DYNACOR LUBRICATION GEL (May 10, 2011)
  • K101522 — ULTRA SEAL STERILE LUBRICATING JELLY (December 23, 2010)
  • K092488 — DYNAREX STERILE LUBRICATING JELLY (December 18, 2009)
  • K083189 — STERI-LUB LUBRICATION GEL (November 21, 2008)
  • K073684 — SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL (May 22, 2008)

FDA data resources