The following data is part of a premarket notification filed by Centrix, Inc. with the FDA for Steribase (accubase).
Device ID | K933999 |
510k Number | K933999 |
Device Name: | STERIBASE (ACCUBASE) |
Classification | Liner, Cavity, Calcium Hydroxide |
Applicant | CENTRIX, INC. 770 RIVER RD. Shelton, CT 06484 -5458 |
Contact | John Discko |
Correspondent | John Discko CENTRIX, INC. 770 RIVER RD. Shelton, CT 06484 -5458 |
Product Code | EJK |
CFR Regulation Number | 872.3250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-17 |
Decision Date | 1994-01-05 |