510(k) K160755
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)