510(k) K233302

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2023
Date Received
September 29, 2023
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