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510(k) K092488

DYNAREX STERILE LUBRICATING JELLY by Dynarex Corporation — Product Code KMJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2009
Date Received
August 13, 2009
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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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)
  • K083189 — STERI-LUB LUBRICATION GEL (November 21, 2008)
  • K073684 — SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL (May 22, 2008)