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510(k) K983374

AGATHA-A-H2010 by Midian Intl. — Product Code EFS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1998
Date Received
September 25, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Oral Irrigation
Device Class
Class I
Regulation Number
872.6510
Review Panel
DE
Submission Type

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