510(k) K030859
K030859 is an FDA 510(k) premarket notification submitted by Enamelite, LLC for the device "NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN". The FDA issued a decision of Substantially Equivalent on March 27, 2003. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Enamelite, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2003
- Date Received
- March 18, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powder, Porcelain
- Device Class
- Class II
- Regulation Number
- 872.6660
- Review Panel
- DE
- Submission Type