The following data is part of a premarket notification filed by Nobelpharma Usa, Inc. with the FDA for Nobelpharma Drilling Equipment Dec 500.
Device ID | K905436 |
510k Number | K905436 |
Device Name: | NOBELPHARMA DRILLING EQUIPMENT DEC 500 |
Classification | Implant, Endosseous, Root-form |
Applicant | NOBELPHARMA USA, INC. 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606 |
Contact | Thomas Muldoon |
Correspondent | Thomas Muldoon NOBELPHARMA USA, INC. 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-04 |
Decision Date | 1991-03-04 |