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510(k) K864556

AQUALUBE(TM) by Parker Laboratories, Inc. — Product Code KMJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1986
Date Received
November 19, 1986
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

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  • K921695 — ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS (February 23, 1995)
  • K861239 — ACRYLIC SOLDER (April 17, 1986)
  • K855167 — DYNA SYSTEM (March 4, 1986)
  • K851895 — POLYGEL ULTRASOUND GEL (September 27, 1985)
  • K852956 — CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION (August 9, 1985)
  • K841400 — NEURO PULSE (June 15, 1984)
  • K840548 — RESIL (April 17, 1984)
  • K831039 — COMPLUS VARIOUS FORMS (May 27, 1983)

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)
  • K113689 — DUKAL LUBRICATING JELLY (May 4, 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)