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510(k) K854155

STERILE SALINE SOLUTION by I M, Inc. — Product Code KMJ

K854155 is an FDA 510(k) premarket notification submitted by I M, Inc. for the device "STERILE SALINE SOLUTION". The FDA issued a decision of Substantially Equivalent on December 10, 1985. The device falls under product code KMJ (Lubricant, Patient), a Class I device regulated under 21 CFR 880.6375. I M, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1985
Date Received
October 11, 1985
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 I M, Inc.

  • K914600 — NEUROLOGICAL SPONGE (December 30, 1992)
  • K892389 — BIOPSY KIT (July 17, 1989)
  • K881363 — SYRINGE PREFILLED WITH WATER (June 23, 1988)
  • K880753 — UMBILICAL CORD CLAMP (April 27, 1988)
  • K872741 — NUTRIPUMP (October 20, 1987)
  • K871495 — BANDAGES CATALOG NUMBER: 101 TO 220 (May 8, 1987)
  • K863785 — MAKLER CATHETER (December 11, 1986)
  • K853287 — HUBOUT (October 17, 1985)
  • K853288 — FEEDING UNITS & TUBES (October 4, 1985)
  • K853286 — STAPLE REMOVER (August 21, 1985)

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