510(k) K241932

OSSIOfiber® Compression Staple by OSSIO , Ltd. — Product Code MNU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2024
Date Received
July 1, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Absorbable
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type