The following data is part of a premarket notification filed by Almore Intl., Inc. with the FDA for Microfil Contouring Instruments.
Device ID | K830776 |
510k Number | K830776 |
Device Name: | MICROFIL CONTOURING INSTRUMENTS |
Classification | Instrument, Filling, Plastic, Dental |
Applicant | ALMORE INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EIY |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-11 |
Decision Date | 1983-04-28 |