510(k) K152745
K152745 is an FDA 510(k) premarket notification submitted by Microline Surgical, Inc. for the device "ReNew Sterilization Trays(Catalog #3708 and #3709)". The FDA issued a decision of Substantially Equivalent on May 12, 2016. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Microline Surgical, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 12, 2016
- Date Received
- September 23, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Device Class
- Class II
- Regulation Number
- 880.6850
- Review Panel
- HO
- Submission Type