510(k) K250306
K250306 is an FDA 510(k) premarket notification submitted by Propper Manufacturing Co., Inc. for the device "Chex-All Sterilization Pouches and Tubes". The FDA issued a decision of Substantially Equivalent on October 31, 2025. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Propper Manufacturing Co., Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 2025
- Date Received
- February 3, 2025
- Clearance Type
- Abbreviated
- 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