510(k) K230137

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

K230137 is an FDA 510(k) premarket notification submitted by Ahlstrom-Munksjo Nonwovens, LLC for the device "Reliance® Fusion Sterilization Wraps". The FDA issued a decision of Substantially Equivalent on December 7, 2023. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850.

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