510(k) K090938

FLOW CONTROLLER by Odyssey Medical, Inc. — Product Code LZU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2009
Date Received
April 3, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plug, Punctum
Device Class
Class U
Regulation Number
Review Panel
OP
Submission Type