The following data is part of a premarket notification filed by Kreativ, Inc. with the FDA for Kreativ Kuring Light System.
Device ID | K962376 |
510k Number | K962376 |
Device Name: | KREATIV KURING LIGHT SYSTEM |
Classification | Material, Tooth Shade, Resin |
Applicant | KREATIV, INC. 1517 INDUSTRIAL WAY, S.W. Albany, OR 97321 |
Contact | Charles W Whutchins |
Correspondent | Charles W Whutchins KREATIV, INC. 1517 INDUSTRIAL WAY, S.W. Albany, OR 97321 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-20 |
Decision Date | 1997-03-21 |