510(k) K130927
K130927 is an FDA 510(k) premarket notification submitted by Cardinal Health200, LLC for the device "DURABLUE STERILIZATION WRAP". The FDA issued a decision of Substantially Equivalent on June 18, 2013. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Cardinal Health200, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 18, 2013
- Date Received
- April 3, 2013
- Clearance Type
- Special
- 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