510(k) K250321
K250321 is an FDA 510(k) premarket notification submitted by George Courey, Inc. for the device "GCI Sterilization Wrappers". The FDA issued a decision of Substantially Equivalent on June 6, 2025. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. George Courey, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 2025
- Date Received
- February 4, 2025
- 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