The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Statusblue.
Device ID | K013237 |
510k Number | K013237 |
Device Name: | STATUSBLUE |
Classification | Material, Impression |
Applicant | DMG USA, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
Contact | Pamela Papineau |
Correspondent | Pamela Papineau DMG USA, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-09-28 |
Decision Date | 2001-10-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
EDMG9996938 | K013237 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() STATUSBLUE 78917634 not registered Dead/Abandoned |
Wills, John 2006-06-27 |
![]() STATUSBLUE 76241729 2921049 Live/Registered |
Muhlbauer Technology GmbH 2001-04-16 |