510(k) K160755

Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap by Ahlstrom Nonwovens, LLC — Product Code FRG

K160755 is an FDA 510(k) premarket notification submitted by Ahlstrom Nonwovens, LLC for the device "Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap". The FDA issued a decision of Substantially Equivalent on Jul 27, 2016. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Ahlstrom Nonwovens, LLC has 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 27, 2016
Date Received
Mar 18, 2016
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
510(k)