The following data is part of a premarket notification filed by Allomedic with the FDA for Riess-luhr.
Device ID | K811113 |
510k Number | K811113 |
Device Name: | RIESS-LUHR |
Classification | Drill, Dental, Intraoral |
Applicant | ALLOMEDIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DZA |
CFR Regulation Number | 872.4130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-04-23 |
Decision Date | 1981-06-16 |