510(k) K192641
K192641 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "Gemini Titan Sterilization Wrap". The FDA issued a decision of Substantially Equivalent on Jan 24, 2020. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Medline Industries, Inc. has 268 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 24, 2020
- Date Received
- Sep 24, 2019
- 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)