510(k) K192088
K192088 is an FDA 510(k) premarket notification submitted by Antarma, LLC Dba Golnit Sutures for the device "GOLNIT Non-aborbable PTFE Surgical Suture". The FDA issued a decision of Substantially Equivalent on September 4, 2019. The device falls under product code NBY (Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene), a Class II device regulated under 21 CFR 878.5035. Antarma, LLC Dba Golnit Sutures has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 4, 2019
- Date Received
- August 5, 2019
- 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