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510(k) K220419

Apapro Desensitizer by Sangi Co, Ltd. — Product Code LBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2022
Date Received
February 14, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Varnish, Cavity
Device Class
Class II
Regulation Number
872.3260
Review Panel
DE
Submission Type

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