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510(k) K092943

ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE by Arnold Tuber Industries — Product Code EJI

K092943 is an FDA 510(k) premarket notification submitted by Arnold Tuber Industries for the device "ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE". The FDA issued a decision of Substantially Equivalent on December 11, 2009. The device falls under product code EJI (Syringe, Cartridge), a Class II device regulated under 21 CFR 872.6770.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2009
Date Received
September 24, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Cartridge
Device Class
Class II
Regulation Number
872.6770
Review Panel
DE
Submission Type

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  • K142414 — Miltex N-Tralig Intraligamentary Syringe (October 30, 2014)
  • K120659 — HU-FRIEDY DENTAL CARTRIDGE SYRINGE (November 6, 2012)
  • K113247 — ANESTHESIA INJECTION TOOL SET (March 27, 2012)
  • K082249 — MORPHEUS (December 31, 2009)
  • K083796 — MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRAT (March 9, 2009)
  • K081694 — DENJECTOR (September 12, 2008)
  • K061904 — COMPUDENT STA (August 8, 2006)
  • K043322 — MIRAMATIC SAFE SYRINGE SYSTEM (July 21, 2005)
  • K040671 — EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING (December 14, 2004)

FDA data resources