510(k) K093019
K093019 is an FDA 510(k) premarket notification submitted by Enamelite, LLC for the device "ENAMELITE ACRYSEAL SPRAY SEALANT". The FDA issued a decision of Substantially Equivalent on December 22, 2009. The device falls under product code EBD (Coating, Filling Material, Resin), a Class II device regulated under 21 CFR 872.3310. Enamelite, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2009
- Date Received
- September 29, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coating, Filling Material, Resin
- Device Class
- Class II
- Regulation Number
- 872.3310
- Review Panel
- DE
- Submission Type