The following data is part of a premarket notification filed by Satelec with the FDA for Suni Max.
Device ID | K000049 |
510k Number | K000049 |
Device Name: | SUNI MAX |
Classification | Handpiece, Air-powered, Dental |
Applicant | SATELEC 70 WALNUT ST. Wellesley, MA 02481 |
Contact | Jacqueline E Masse |
Correspondent | Jacqueline E Masse SATELEC 70 WALNUT ST. Wellesley, MA 02481 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-01-07 |
Decision Date | 2000-04-04 |