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510(k) K073684

SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL by Sheffield Industries, Div. of Faria , Ltd. — Product Code KMJ

K073684 is an FDA 510(k) premarket notification submitted by Sheffield Industries, Div. of Faria , Ltd. for the device "SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL". The FDA issued a decision of Substantially Equivalent on May 22, 2008. The device falls under product code KMJ (Lubricant, Patient), a Class I device regulated under 21 CFR 880.6375.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2008
Date Received
December 28, 2007
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 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)

FDA data resources