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510(k) K190144

MucoPEG by Sunbio, Inc. — Product Code LFD

K190144 is an FDA 510(k) premarket notification submitted by Sunbio, Inc. for the device "MucoPEG". The FDA issued a decision of Substantially Equivalent on November 5, 2019. The device falls under product code LFD (Saliva, Artificial), a Class U device.

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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FDA data resources