510(k) K040707
K040707 is an FDA 510(k) premarket notification submitted by Vygon Us, LLC for the device "PACKAGING TRAY AND COMPONENTS". The FDA issued a decision of Substantially Equivalent on Apr 16, 2004. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Vygon Us, LLC has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 16, 2004
- Date Received
- Mar 18, 2004
- Clearance Type
- Special
- 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)