510(k) K193209
K193209 is an FDA 510(k) premarket notification submitted by Foosin Medical Supplies Inc., Ltd. for the device "Wego-Stainless Steel". The FDA issued a decision of Substantially Equivalent on February 19, 2020. The device falls under product code GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile), a Class II device regulated under 21 CFR 878.4495. Foosin Medical Supplies Inc., Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 2020
- Date Received
- November 21, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- Device Class
- Class II
- Regulation Number
- 878.4495
- Review Panel
- SU
- Submission Type