The following data is part of a premarket notification filed by Advanced Marketing Research Co. with the FDA for Advanced Denture System.
Device ID | K780722 |
510k Number | K780722 |
Device Name: | ADVANCED DENTURE SYSTEM |
Classification | Denture Preformed (partially Prefabricated Denture) |
Applicant | ADVANCED MARKETING RESEARCH CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EKO |
CFR Regulation Number | 872.3600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-05-01 |
Decision Date | 1978-05-26 |