510(k) K171533

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

K171533 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 Jun 29, 2017. 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
Jun 29, 2017
Date Received
May 25, 2017
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)