510(k) K092319
K092319 is an FDA 510(k) premarket notification submitted by Danville Materials, Inc. for the device "STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387". The FDA issued a decision of Substantially Equivalent on September 16, 2009. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Danville Materials, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 2009
- Date Received
- August 4, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Impression
- Device Class
- Class II
- Regulation Number
- 872.3660
- Review Panel
- DE
- Submission Type