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510(k) K910832

OXYFRESH OXYCARE 3000 by Oxyfresh — Product Code EFS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1991
Date Received
February 27, 1991
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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