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510(k) K190144

MucoPEG by Sunbio, Inc. — Product Code LFD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2019
Date Received
January 29, 2019
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

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