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510(k) K183501

Parcus Twist AP Suture Anchors by Parcus Medical, LLC — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2019
Date Received
December 17, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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