The following data is part of a premarket notification filed by Dci with the FDA for Dci Edge Dental Chair With Operative Unit.
Device ID | K151987 |
510k Number | K151987 |
Device Name: | DCI Edge Dental Chair With Operative Unit |
Classification | Chair, Dental, With Operative Unit |
Applicant | DCI 305 N. SPRINGBROOK RD. Newberg, OR 97132 |
Contact | Robert Bellingham |
Correspondent | Robert Bellingham DCI 305 N. SPRINGBROOK RD. Newberg, OR 97132 |
Product Code | KLC |
CFR Regulation Number | 872.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-17 |
Decision Date | 2016-06-01 |
Summary: | summary |