510(k) K234132
K234132 is an FDA 510(k) premarket notification submitted by Medline Industries, LP for the device "Medline Reusable Sterilization Wrappers". The FDA issued a decision of Substantially Equivalent on September 17, 2024. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Medline Industries, LP has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2024
- Date Received
- December 28, 2023
- 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