The following data is part of a premarket notification filed by J.l. Blosser, Inc. with the FDA for Resiment With Fluoride.
Device ID | K933459 |
510k Number | K933459 |
Device Name: | RESIMENT WITH FLUORIDE |
Classification | Cement, Dental |
Applicant | J.L. BLOSSER, INC. 22 NORTH MAIN ST. Liberty, MO 64068 |
Contact | Larry L Blosser |
Correspondent | Larry L Blosser J.L. BLOSSER, INC. 22 NORTH MAIN ST. Liberty, MO 64068 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-14 |
Decision Date | 1993-10-20 |