510(k) K230137

Reliance® Fusion Sterilization Wraps by Ahlstrom-Munksjo Nonwovens, LLC — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2023
Date Received
January 18, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type