The following data is part of a premarket notification filed by J.b.c And Co. with the FDA for Jbc Opaque And Glitter.
Device ID | K002048 |
510k Number | K002048 |
Device Name: | JBC OPAQUE AND GLITTER |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | J.B.C AND CO. 6280 SOUTH VALLEY VIEW BLVD., #122 Las Vegas, NV 89118 |
Contact | Priscilla L Mier |
Correspondent | Priscilla L Mier J.B.C AND CO. 6280 SOUTH VALLEY VIEW BLVD., #122 Las Vegas, NV 89118 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-06-26 |
Decision Date | 2000-08-30 |