510(k) K082249

MORPHEUS by Meibach Tech Ltda — Product Code EJI

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