510(k) K061331

ORAL BALANCE LIQUID/ GEL by Laclede, Inc. — Product Code LFD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2006
Date Received
May 12, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saliva, Artificial
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type