The following data is part of a premarket notification filed by Danville Materials, Inc. with the FDA for Star Vps, Model 80014-01, First Quater, Model 90649, First Half, Model 89387.
Device ID | K092319 |
510k Number | K092319 |
Device Name: | STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387 |
Classification | Material, Impression |
Applicant | DANVILLE MATERIALS, INC. 3420 FOSTORIA WAY, SUITE A-200 San Ramon, CA 94583 |
Contact | Craig Bruns |
Correspondent | Craig Bruns DANVILLE MATERIALS, INC. 3420 FOSTORIA WAY, SUITE A-200 San Ramon, CA 94583 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-08-04 |
Decision Date | 2009-09-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850007728243 | K092319 | 000 |