510(k) K220365
K220365 is an FDA 510(k) premarket notification submitted by Medline Industries, LP for the device "Gemini Sterilization Wrap". The FDA issued a decision of Substantially Equivalent on Oct 6, 2022. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Medline Industries, LP has 268 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 6, 2022
- Date Received
- Feb 8, 2022
- 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)