The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Honigum.
Device ID | K000878 |
510k Number | K000878 |
Device Name: | HONIGUM |
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 | 2000-03-20 |
Decision Date | 2000-04-11 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
EDMG9998398 | K000878 | 000 |
EDMG9898318 | K000878 | 000 |
EDMG9898308 | K000878 | 000 |
EDMG9897671 | K000878 | 000 |
EDMG9897668 | K000878 | 000 |
EDMG9896398 | K000878 | 000 |
EDMG9896388 | K000878 | 000 |
EDMG9895688 | K000878 | 000 |
EDMG9895398 | K000878 | 000 |
EDMG9895378 | K000878 | 000 |
EDMG9895021 | K000878 | 000 |
EDMG9895011 | K000878 | 000 |
EDMG9898328 | K000878 | 000 |
EDMG9898388 | K000878 | 000 |
EDMG9993748 | K000878 | 000 |
EDMG9998388 | K000878 | 000 |
EDMG9998328 | K000878 | 000 |
EDMG9998318 | K000878 | 000 |
EDMG9998308 | K000878 | 000 |
EDMG9997668 | K000878 | 000 |
EDMG9996398 | K000878 | 000 |
EDMG9996388 | K000878 | 000 |
EDMG9995688 | K000878 | 000 |
EDMG9995398 | K000878 | 000 |
EDMG9995378 | K000878 | 000 |
EDMG9995001 | K000878 | 000 |
EDMG9893748 | K000878 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HONIGUM 75284826 2192011 Live/Registered |
Muhlbauer Technology GmbH 1997-05-01 |