The following data is part of a premarket notification filed by Alpine Dental Equipment Co. with the FDA for Area (dental Chair).
Device ID | K880474 |
510k Number | K880474 |
Device Name: | AREA (DENTAL CHAIR) |
Classification | Chair, Dental, With Operative Unit |
Applicant | ALPINE DENTAL EQUIPMENT CO. 325 ELMWOOD AVE. East Orange, NJ 07018 |
Contact | Norman Smith |
Correspondent | Norman Smith ALPINE DENTAL EQUIPMENT CO. 325 ELMWOOD AVE. East Orange, NJ 07018 |
Product Code | KLC |
CFR Regulation Number | 872.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-04 |
Decision Date | 1988-09-23 |