510(k) K092319

STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387 by Danville Materials, Inc. — Product Code ELW

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