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510(k) K812297

A.D.T. PROCEDURES TRAY by A.D.T. Lab Industries — Product Code KMJ

K812297 is an FDA 510(k) premarket notification submitted by A.D.T. Lab Industries for the device "A.D.T. PROCEDURES TRAY". The FDA issued a decision of Substantially Equivalent on September 28, 1981. The device falls under product code KMJ (Lubricant, Patient), a Class I device regulated under 21 CFR 880.6375. A.D.T. Lab Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1981
Date Received
August 14, 1981
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 A.D.T. Lab Industries

  • K801753 — ADT BONE MARROW BIOPSY-ASPIR. NEELDE (August 20, 1980)
  • K801754 — ADT BONE MARROW ASPIRATION NEEDLE (August 20, 1980)
  • K800409 — ADT BONE MARROW BIOPSY ASPIRATION TRAY (April 28, 1980)
  • K800408 — ADT BONE MAR. BIO/ASP. TRAY W/NEEDLE (April 28, 1980)
  • K800412 — ROSENTHAL NEEDLE (DISP.) ADT BONE MARROW (April 28, 1980)
  • K800410 — ADT BONE MARROW BIOPSY-ASPIRATION TRAY (April 28, 1980)
  • K800417 — ADT PTC PRO. TRAY W/(SKINNY CHIBA) NEEDL (April 28, 1980)
  • K800418 — ADT DISPOSABLE THIN NEEDLE ASPIRATION (April 28, 1980)
  • K800414 — ADT SOFT TISSUE BIOPSY TRAY (April 28, 1980)
  • K800411 — ASPIRATION TRAY W/FERRIS DISP. ILLINOIS (April 28, 1980)

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