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510(k) K082249

MORPHEUS by Meibach Tech Ltda — Product Code EJI

K082249 is an FDA 510(k) premarket notification submitted by Meibach Tech Ltda for the device "MORPHEUS". The FDA issued a decision of Substantially Equivalent on December 31, 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 31, 2009
Date Received
August 8, 2008
Clearance Type
Abbreviated
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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  • K113247 — ANESTHESIA INJECTION TOOL SET (March 27, 2012)
  • K092943 — ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE (December 11, 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