The following data is part of a premarket notification filed by Vident with the FDA for In-ceram Spinell.
Device ID | K951183 |
510k Number | K951183 |
Device Name: | IN-CERAM SPINELL |
Classification | Powder, Porcelain |
Applicant | VIDENT 5130 COMMERCE DR. Baldwin Park, CA 91706 |
Contact | Ray E Morrow |
Correspondent | Ray E Morrow VIDENT 5130 COMMERCE DR. Baldwin Park, CA 91706 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-16 |
Decision Date | 1995-05-02 |