The following data is part of a premarket notification filed by Vident with the FDA for Vita Response.
Device ID | K000597 |
510k Number | K000597 |
Device Name: | VITA RESPONSE |
Classification | Powder, Porcelain |
Applicant | VIDENT 3150 EAST BIRCH ST. Brea, CA 92821 |
Contact | Barbara J Lewandowski |
Correspondent | Barbara J Lewandowski VIDENT 3150 EAST BIRCH ST. Brea, CA 92821 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-02-22 |
Decision Date | 2000-05-17 |