510(k) K221875
K221875 is an FDA 510(k) premarket notification submitted by Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. for the device "Sterilization Pouch and Roll". The FDA issued a decision of Substantially Equivalent on Feb 13, 2023. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 13, 2023
- Date Received
- Jun 28, 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)