The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Jetlite 5000.
Device ID | K051780 |
510k Number | K051780 |
Device Name: | JETLITE 5000 |
Classification | Activator, Ultraviolet, For Polymerization |
Applicant | J. MORITA USA, INC. 9 MASON Irvine, CA 92618 |
Contact | Howard Rowe |
Correspondent | Howard Rowe J. MORITA USA, INC. 9 MASON Irvine, CA 92618 |
Product Code | EBZ |
CFR Regulation Number | 872.6070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-07-01 |
Decision Date | 2005-07-28 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
JETLITE 5000 78801501 3162753 Dead/Cancelled |
J. Morita USA, Inc. 2006-01-27 |