510(k) K170842
K170842 is an FDA 510(k) premarket notification submitted by Foosin Medical Supplies Inc., Ltd. for the device "WEGO-PTFE". The FDA issued a decision of Substantially Equivalent on July 31, 2017. The device falls under product code NBY (Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene), a Class II device regulated under 21 CFR 878.5035. Foosin Medical Supplies Inc., Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 2017
- Date Received
- March 21, 2017
- Clearance Type
- Traditional
- 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