The following data is part of a premarket notification filed by Dale T. Dupuis with the FDA for Dentrek Bridge Bars.
Device ID | K883388 |
510k Number | K883388 |
Device Name: | DENTREK BRIDGE BARS |
Classification | Bar, Preformed |
Applicant | DALE T. DUPUIS 912 NORTH UNION Opelousas, LA 70570 |
Contact | Dupuis, Dds |
Correspondent | Dupuis, Dds DALE T. DUPUIS 912 NORTH UNION Opelousas, LA 70570 |
Product Code | EHO |
CFR Regulation Number | 872.3165 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-10 |
Decision Date | 1988-10-06 |