510(k) K180630
K180630 is an FDA 510(k) premarket notification submitted by Omnia Spa for the device "PTFE SURGICAL SUTURE". The FDA issued a decision of Substantially Equivalent on April 6, 2018. The device falls under product code NBY (Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene), a Class II device regulated under 21 CFR 878.5035. Omnia Spa has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 2018
- Date Received
- March 9, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
- Device Class
- Class II
- Regulation Number
- 878.5035
- Review Panel
- SU
- Submission Type