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510(k) K211612

Medline UNITE REFLEX Dynamic Discs by Medline Industries, Inc. — Product Code HTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2021
Date Received
May 26, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Washer, Bolt Nut
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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