510(k) K060465
K060465 is an FDA 510(k) premarket notification submitted by Peters Surgical for the device "PREMIO". The FDA issued a decision of Substantially Equivalent on January 17, 2007. The device falls under product code MXW (Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)), a Class II device regulated under 21 CFR 878.5010. Peters Surgical has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 2007
- Date Received
- February 22, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)
- Device Class
- Class II
- Regulation Number
- 878.5010
- Review Panel
- SU
- Submission Type