510(k) K212338
K212338 is an FDA 510(k) premarket notification submitted by Sterileright Packaging Mfg., Inc. for the device "SterileRight sterilization pouch and roll". The FDA issued a decision of Substantially Equivalent on Nov 1, 2021. 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
- Nov 1, 2021
- Date Received
- Jul 27, 2021
- 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)