The following data is part of a premarket notification filed by Alpine Dental Equipment Co. with the FDA for Solar Cart.
Device ID | K854642 |
510k Number | K854642 |
Device Name: | SOLAR CART |
Classification | Unit, Operative Dental |
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 | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-11-19 |
Decision Date | 1986-03-14 |