510(k) K191299
K191299 is an FDA 510(k) premarket notification submitted by Silhouette Lift, Inc. for the device "Silhouette Featherlift / Silhouette Lift". The FDA issued a decision of Substantially Equivalent on June 14, 2019. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Silhouette Lift, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 2019
- Date Received
- May 14, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Synthetic, Polypropylene
- Device Class
- Class II
- Regulation Number
- 878.5010
- Review Panel
- SU
- Submission Type