510(k) K082218

MAX ADJUSTING INSTRUMENT by Manna Omni International, Inc. — Product Code LXM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2008
Date Received
August 6, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manipulator, Plunger-Like Joint
Device Class
Class U
Regulation Number
Review Panel
PM
Submission Type