510(k) K162366
K162366 is an FDA 510(k) premarket notification submitted by Ov World Co., Ltd. for the device "Omega VL". The FDA issued a decision of Substantially Equivalent on Mar 2, 2018. The device falls under product code NEW (Suture, Surgical, Absorbable, Polydioxanone), a Class II device regulated under 21 CFR 878.4840.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 2, 2018
- Date Received
- Aug 23, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Surgical, Absorbable, Polydioxanone
- Device Class
- Class II
- Regulation Number
- 878.4840
- Review Panel
- SU
- Submission Type
- 510(k)