The following data is part of a premarket notification filed by Vident with the FDA for Vita Pm 7 (20 Gram Bottles), Vita Pm 7 (50 Gram Bottles).
Device ID | K050362 |
510k Number | K050362 |
Device Name: | VITA PM 7 (20 GRAM BOTTLES), VITA PM 7 (50 GRAM BOTTLES) |
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 | 2005-02-14 |
Decision Date | 2005-03-15 |