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510(k) K980363

ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI) by Orofacial Dynamics — Product Code LBB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1998
Date Received
January 29, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dynamometer, Ac-Powered
Device Class
Class II
Regulation Number
888.1240
Review Panel
NE
Submission Type

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