The following data is part of a premarket notification filed by Dentalez Group with the FDA for E 4000 Dental Operating Chair.
Device ID | K925567 |
510k Number | K925567 |
Device Name: | E 4000 DENTAL OPERATING CHAIR |
Classification | Chair, Dental, With Operative Unit |
Applicant | DENTALEZ GROUP 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
Contact | William A.lambertson |
Correspondent | William A.lambertson DENTALEZ GROUP 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
Product Code | KLC |
CFR Regulation Number | 872.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-03 |
Decision Date | 1994-03-10 |